nih-gov/heal.nih.gov/funding/awarded?research_program=42111&page=3
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<select aria-label="Research Focus Area" data-drupal-selector="edit-rfa" id="edit-rfa" name="rfa" class="form-select"><option value="All" selected="selected">Research Focus Area</option><option value="81">Clinical Research in Pain Management</option><option value="40331">Cross-Cutting Research</option><option value="71">Enhanced Outcomes for Infants and Children Exposed to Opioids</option><option value="66">New Strategies to Prevent and Treat Opioid Addiction</option><option value="76">Novel Therapeutic Options for Opioid Use Disorder and Overdose</option><option value="86">Preclinical and Translational Research in Pain Management</option><option value="46831">Training the Next Generation of Researchers in HEAL</option><option value="61">Translation of Research to Practice for the Treatment of Opioid Addiction</option></select>
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<select aria-label="Research Program" data-drupal-selector="edit-research-program" id="edit-research-program" name="research_program" class="form-select"><option value="All">Research Program</option><option value="186">Acute to Chronic Pain Signatures Program</option><option value="136">Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)</option><option value="42106">Advancing Health Equity in Pain Management </option><option value="161">Back Pain Consortium Research Program</option><option value="106">Behavioral Research to Improve Medication-Based Treatment</option><option value="42126">Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)</option><option value="206">Development and Optimization of Non-Addictive Therapies to Treat Pain</option><option value="151">Development of Novel Immunotherapeutics for Opioid Addiction</option><option value="191">Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions</option><option value="216">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</option><option value="176">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</option><option value="96">Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids</option><option value="146">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</option><option value="41416">Harm Reduction Research Network</option><option value="42121">HEAL Data2Action (HD2A)</option><option value="91">HEALing Communities Study</option><option value="141">HEALthy Brain and Child Development (HBCD) Study</option><option value="42146">Improving Delivery of Healthcare Services for Polysubstance Use</option><option value="181">Integrated Approach to Pain and Opioid Use in Hemodialysis Patients</option><option value="44116">Integrated Basic and Clinical Team-Based Research in Pain</option><option value="101">Justice Community Overdose Innovation Network (JCOIN)</option><option value="42116">Leveraging Existing and Real-Time Opioid and Pain Management Data</option><option value="42586">Native Collective Research Effort to Enhance Wellness (N CREW) Program: Addressing Overdose, Substance Use, Mental Health, and Pain </option><option value="111">Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions</option><option value="126">Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for Opioid Use Disorder</option><option value="44086">Optimizing the Quality, Reach, and Impact of Addiction Services</option><option value="44106">Oral Complications Arising From Pharmacotherapies to Treat Opioid Use Disorders</option><option value="166">Pain Management Effectiveness Research Network (ERN)</option><option value="171">Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)</option><option value="211">Preclinical Screening Platform for Pain</option><option value="116">Preventing Opioid Use Disorder </option><option value="44091">Prevention and Management of Chronic Pain in Rural Populations</option><option value="131">Prevention of Progression to Moderate or Severe Opioid Use Disorder</option><option value="44111">Rapidly Assessing the Public Health Impact of Emerging Opioid Threats</option><option value="39646">Recovery Research Networks</option><option value="39621">Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL)</option><option value="42136">Restoring Joint Health and Function to Reduce Pain (RE-JOIN)</option><option value="121">Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery</option><option value="42111" selected="selected">Small Business Programs</option><option value="40256">Stigma in Pain Management and Opioid Use Disorder</option><option value="44096">The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development</option><option value="42151">The Continuum of Care in Hospitalized Patients with Opioid Use Disorder and Infectious Complications of Drug Use (CHOICE)</option><option value="201">Translating Discoveries into Effective Devices to Treat Pain</option><option value="196">Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder</option><option value="44101">Virtual Assessments to Understand Developmental Trajectories of Substance Use Exposure</option></select>
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<th id="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number" scope="col"><a href="?page=3&amp;research_program=42111&amp;rfa=All&amp;institutions1=&amp;locations1=&amp;goal=All&amp;combine=&amp;grant=All&amp;locations=&amp;institutions=&amp;select_location=All&amp;year=&amp;items_per_page=25&amp;order=field_reporter_number&amp;sort=asc" title="sort by Project #">Project #</a></th>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34471"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9869738" target="_blank">1R61AT010800-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCCIH </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UCLA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GLASNER-EDWARDS, SUZETTE V </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Los Angeles, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-at-19-006.html" target="_blank">RFA-AT-19-006</a>
<br>
<strong>Summary:</strong>
<br>
<p>Medications for the treatment of opioid use disorders (MOUD) are effective at reducing opioid use, opioid overdose risk, and opioid-related deaths; however, retention and adherence to MOUD treatment, particularly buprenorphine (BUP), are discouragingly low. The objective of the current research is to adapt and extend a cognitive behavioral therapy-based short message system (SMS) intervention (TXT-CBT) to address MOUD treatment retention and adherence using the imFREE (Interactive Messaging for Freedom from Opioid Addiction) platform. imFREE builds upon the efficacious SMS-based TXT-CBT intervention, with content addressing retention and adherence to BUP, including mitigating risk factors for dropout, and features to notify social and provider support contacts in the face of treatment discontinuation and/or other indicators of relapse and overdose risk. By providing support to maximize BUP treatment adherence, coupled with skills to prevent relapse, imFREE may provide a cost-effective, easily deployable strategy for OUD treatment and prevention of overdose deaths.</p>
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<span id="project-title-34741"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9680488&amp;amp;icde=44817808" target="_blank">1R41DA047779-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">DEVELOPMENT OF A TRACHEAL SOUND SENSOR FOR EARLY DETECTION OF HYPOVENTILATION DUE TO OPIOID OVERDOSE. </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">RTM Vital Signs, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Joseph, Jeffrey I </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">FORT WASHINGTON, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-575.html" target="_blank">PA-18-575</a>
<br>
<strong>Summary:</strong>
<br>
<p>One of the current critical needs in addressing the opioid crisis is the development of new overdose-reversal interventions, including wearable technologies that can detect an (impending) overdose from physiological signals to signal for help, or trigger a coupled automated injection of naloxone. This project tests the approach of monitoring respiration by detecting the sounds of breathing in the trachea. This proposal aims to develop a machine learning algorithm that could process those sounds, detect the kinds of patterns of reduced breathing that occur during an opioid overdose, and design a miniature wireless sensor that could be used to detect those sounds. Such a sensor and algorithm could be a key component to a device to detect and intervene in overdoses.</p>
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<span id="project-title-34881"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9776979&amp;amp;icde=44817700" target="_blank">1R43DA049300-01A1</a>
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<td headers="view-title-table-column" class="views-field views-field-title">PRAPELA™ SVS: A COST-EFFECTIVE STOCHASTIC VIBROTACTILE STIMULATION DEVICE TO IMPROVE THE CLINICAL COURSE OF INFANTS WITH NEONATAL ABSTINENCE SYNDROME </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">PRAPELA, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KONSIN, JOHN PHILLIP (contact); SINGH, RACHANA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Concord, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Maternal use and addiction to opioids or other drugs has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal abstinence syndrome (NAS). While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended as an initial course of treatment. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources. This project studies the technical feasibility of a stochastic vibrotactile stimulation (SVS) technology incorporated into the hospital bassinet pad, which provides gentle vibrating sensory stimulation to soothe infants with NAS. Building on preliminary evidence that this type of stimulation calms NAS infants without altering their sleep, this study aims to develop a commercially viable bassinet pad that could be used in a hospital setting.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35046"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9845965" target="_blank">1R43NS113726-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Pharmacokinetic and toxicology studies of AYX2, a transcription factor decoy, non-opioid, disease modifying drug candidate for the long-term treatment of chronic pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ADYNXX, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MAMET, JULIEN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Francisco, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic focal neuropathic pain, which includes pain etiologies such as radiculopathy and radiculitis, focal peripheral neuropathies, and low back pain, affects as many as 25 million patients annually in the United States. Chronic focal neuropathic pain is maintained by genome-wide transcription regulation in the dorsal root ganglia (DRG) / spinal cord network. The transcription factors driving this regulation constitute a promising class of targets with the potential to alter the course of pain with a single treatment. DNA decoys are oligonucleotides that specifically inhibit the activity of certain transcription factors. AYX2 binds and inhibits Krüppel-like transcription factors (KLF) in the DRG-spinal cord. The goal of this Phase 1 proposal is to advance AYX2 toward an IND submission, allowing for human clinical trials. We propose in Aim 1 to characterize AYX2 pharmacokinetics in the cerebrospinal fluid and plasma and its distribution in the DRG, spinal cord and brain following an IT injection. With this information, AYX2 will be tested in a panel of complementary toxicology studies in Aim 2 to allow for final IND-enabling studies, supported by Phase 2 of the grant. This research will accelerate development of AYX2 as a novel drug candidate for the non-opioid treatment of pain.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35406"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9674683&amp;amp;icde=43814439" target="_blank">1R43DA047722-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">PERIPHERALLY-RESTRICTED AND LONG-ACTING MAS1(LA-MAS1) AGONISTS FOR PAIN </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Peptide Logic, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Riviere, Pierre </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">SAN DIEGO, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>This project seeks to develop a first-in-class (FIC), peripherally restricted and long-acting drug with potential to reduce or replace opioid for moderate to severe pain, and that will be non-addictive, safe, and convenient to use. The program is based on strong scientific evidence showing that activation of a receptor called MAS1 produces opioid-independent and peripheral pain relieving activity in a wide range of animal models of chronic pain, including inflammatory, neuropathic, and bone cancer pain. This project focuses on the development of potent, stable, and specific molecules that stimulate MAS1. Researchers will then attach peptides that stimulate MAS to antibody carriers that make them last longer and selectively affect only the peripheral nervous system, which could allow for once a week or twice a month dosing while maintaining the drugs efficacy and reducing potential side effects, and test the resulting molecule in animal models.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35606"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9850738" target="_blank">3R44TR001326-03S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Automation and validation of human on a chip systems for drug discovery </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCATS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">HESPEROS, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SHULER, MICHAEL L; HICKMAN, JAMES J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Orlando, FL </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-17-302.html" target="_blank">PA-17-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>Hesperos uses microphysiological systems in combination with functional readouts to establish systems capable of analysis of chemicals and drug candidates for toxicity and efficacy during pre-clinical testing, with initial emphasis on predictive toxicity. The team constructed physiological systems that represent cardiac, muscle and liver function, and demonstrated a multi-organ functional cardiac/liver module for toxicity studies as well as metabolic activity evaluations. In addition, the team demonstrated multi-organ toxicity in a 4-organ system composed of neuronal, cardiac, liver and muscle components. While much is known about the cells and neural circuitry regulating pain modulation there is limited knowledge regarding the precise mechanism by which peripheral and spinal level antinociceptive drugs function, and no available human-based model reproducing this part of the pain pathway. The ascending pain modulatory pathways provide a well characterized neural architecture for investigating pain regulatory physiology. In this project, the research team propose a human-on-a-chip neuron tri-culture system composed of nociceptive neurons, GABAergic interneurons and glutamatergic dorsal projection neurons (DPN) integrated with a MEMS construct. Using this model, investigators will interrogate pain signaling physiology at three levels, 1) at the site of origin by targeting nociceptive neurons with pain modulating compounds including noxious stimuli and inflammatory mediators, 2) at the inhibitory GABAergic interneuron, and 3) at the ascending spinal level by targeting glutamatergic DPNs. These circuits will be integrated utilizing expertise in patterning neurons as well as integration with BioMEMs devices. This system provides scientists with a better understanding of ascending pain pathway physiology and enable clinicians to consider alternative indications for treating pain at peripheral and spinal levels.&nbsp;</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35896"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9908734" target="_blank">1R44AR076885-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Enhancing Physical Therapy: Noninvasive Brain Stimulation System for Treating Carpal Tunnel Syndrome </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIAMS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">HIGHLAND INSTRUMENTS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WAGNER, TIMOTHY ANDREW; DIPIETRO, LAURA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cambridge, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-573.html" target="_blank">PA-18-573</a>
<br>
<strong>Summary:</strong>
<br>
<p>&nbsp;Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of chronic pain (CP) in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [25-28]. However, the most common NIBS methods, e.g., transcranial direct current stimulation, have shown limited, if any, efficacy in treating neuropathic pain. It has been postulated that limitations in conventional NIBS techniques focality, penetration, and targeting control limit their therapeutic efficacy . Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue . This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat CP in carpal tunnel syndrome (CTS), both as a lone treatment and in conjunction with physical therapy (PT). Investigators hypothesize ESStim can be provided synergistically with PT, as both can encourage plasticity-dependent changes which could maximally improve a CTS patients pain free mobility. In parallel with the CTS treatments, the team will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics. The computational work will be used to develop an optimized CTS ESStim dosing model.&nbsp;</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-33776"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9621475" target="_blank">1R43NR017575-01A1</a>
</span>
<br>
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<td headers="view-title-table-column" class="views-field views-field-title">Using Virtual Reality Psychological Therapy to Develop a Non-Opioid Chronic Pain Therapy </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">COGNIFISENSE, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BAEUERLE, TASSILO; CEKO, MARTA ; WEBSTER, LYNN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Sunnyvale, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-17-302.html" target="_blank">PA-17-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic pain.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34181"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9782089&amp;amp;icde=41498028" target="_blank">3R42TR001270-03S1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">PERIPHERAL NERVE-ON-A-CHIP FOR PREDICTIVE PRECLINICAL PHARMACEUTICAL TESTING </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCATS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">AXOSIM, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CURLEY, JABE L; MOORE, MICHAEL J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">NEW ORLEANS, LA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2016-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-303.html" target="_blank">PA-16-303</a>
<br>
<strong>Summary:</strong>
<br>
<p>The ability to de-risk lead compounds during pre-clinical development with advanced “organoid-on-a-chip” technologies shows promise. Development of microphysiological models of the peripheral nervous system is lagging. The technology described herein allows for 3D growth of high-density axonal fiber tracts, resembling peripheral nerve anatomy. The use of structural and functional analyses should mean drug-induced neural toxicity will manifest in these measurements in ways that mimic clinical neuropathology. The goals of this proposal are to establish our human model using relevant physiological measurements in tissues fabricated from human iPS cells and to validate the model system with a library of compounds, comparing against conventional cell culture models. Validating the peripheral nerve model system with drugs known to induce toxicity via a range of mechanisms will demonstrate the ability of the system to predict various classifications of neuropathy, yielding a high-content assay far more informative than traditional in vitro systems.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34606"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9778341&amp;amp;icde=44817683" target="_blank">2R44DA043325-02</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">SENSITIVE AND PORTABLE PHYSICIAN OFFICE-BASED URINE ANALYZER TO TACKLE PRESCRIPTION DRUG ABUSE </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">BreviTest Technologies, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Heffernan, Michael John </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">HOUSTON, TX </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. This project, a partnership with BreviTest Technologies, LLC, aims to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for a portable platform to deliver quantitative performance similar to a standard laboratory test for opioids within a 10-minute run time. If successful, this will provide a technology capable of performing rapid quantifications of urine drug levels in a physicians office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way toward lower toxicity and a better quality of life.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34806"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9839289" target="_blank">1R44DA049493-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">A Prescription Digital Therapeutic to Promote Adherence to Buprenorphine Pharmacotherapy for Patients with Opioid Use Disorder </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">PEAR THERAPEUTICS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KERN, AUDREY; PALLONE, DAVINA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Boston, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-014.html" target="_blank">RFA-DA-19-014</a>
<br>
<strong>Summary:</strong>
<br>
<p>Opioid use disorder (OUD) is a key driver of the current opioid epidemic in the United States, but nearly 80% of individuals with OUD do not receive treatment. Buprenorphine medication-assisted treatment (MAT) is an effective form of care for OUD. This project will develop a state-of-the-art, digital therapeutic tool that effectively promotes buprenorphine adherence by providing contingency management rewards and educational content and enables home induction using a new self-monitoring support tool. This tool, named reSET-O+, will be integrated with Pear Therapeutics reSET-O, an FDA market-authorized mobile application delivering validated behavioral therapy and intended for use in conjunction with buprenorphine and standard outpatient treatment for OUD.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34926"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9906345" target="_blank">1R43DA050338-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A universal approach for improving the limit of detection for fentanyl and fentanyl derivatives in urine </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CERES NANOSCIENCES, LLLP </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LEPENE, BENJAMIN SCOTT </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">MANASSAS, VA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html">RFA-DA-19-019</a>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35201"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9845353" target="_blank">1R43NS112088-01A1</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Repression of Sodium Channels via a Gene Therapy for Treatment of Chronic Neuropathic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NAVEGA THERAPEUTICS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MORENO, ANA MARIA; ALEMAN GUILLEN, FERNANDO </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Diego, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<tr id="summary13" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Voltage-gated sodium channels are responsible for the transmission of pain signals. Nine genes have been identified, each having unique properties and tissue distribution patterns. Genetic studies have correlated a hereditary loss-of-function mutation in one human Na+ channel isoform ?Na?V?1.7 with a rare genetic disorder known as Congenital Insensitivity to Pain (CIP). Individuals with CIP are not able to feel pain without any significant secondary alteration. Thus, selective inhibition of ?Na?V?1.7 in normal humans could recapitulate the phenotype of CIP. This research team developed a non-permanent gene therapy to target pain that is non-addictive (because it targets a non-opioid pathway), highly specific (only targeting the gene of interest), and long-term lasting (around 3 weeks in preliminary assays in mice). During this Phase I , the team will 1) test additional pain targets ?in vitro?, and 2) evaluate the new targets ?in vivo ?in mice models of inflammatory and neuropathic pain.&nbsp;</p>
</div>
</td>
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<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35441"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9847335" target="_blank">1R44NS113749-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Micronized salsalate in a parenteral formulation is a safe and effective analgesic for acute postoperative pain management </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">RH NANOPHARMACUETICALS L.L.C. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ROSS, JOEL STEVEN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Monmouth Beach, NJ </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<tr id="summary14" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>There is an unmet need for an effective parenteral/oral analgesic for acute post- operative pain management without the risks of opioid addiction. Salsalate, a dimer or salicylic acid, is currently available in oral dosage for the treatment of osteoarthritis and rheumatoid arthritis. Salsalate works at multiple levels to target multiple steps along the surgical pain pathway. Salsalate through its active metabolite, salicylic acid (SA), reduces NF-?B activation via IKK-kinase beta inhibition, and has no direct binding to cyclooxygenase 1 (Cox-1); therefore, does not affect function of platelets, resulting in a safer hematological and gastrointestinal safety profile. RH Nano proposes a plan for manufacturing and pre- clinical testing of parenteral M-salsalate in two animal models to assess the efficacy and safety in the treatment of acute postoperative pain management. In this proposal, the team will develop the optimal formulation under strict Chemistry Manufacturing and Control guidelines. In Phase II, the team proposes to conduct the pharmacokinetics and toxicology studies of M-salsalate in two species of animals (rodent and non-rodent). Additionally, the project will use an animal pain model for preclinical efficacy studies, and an in vivo Receptor Occupancy assay in animal brain tissues to assess the opioid sparing properties of M-salsalate.&nbsp;</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35661"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9907592" target="_blank">1R43NS115312-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Long-acting ghrelin for neuropathy </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">EXTEND BIOSCIENCES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SOLIMAN, TARIK </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Newton, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<tr id="summary15" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>There is a need for safe, effective, well- tolerated drugs to treat painful neuropathy by halting or reversing the underlying pathology of the disease. One promising approach to treating painful neuropathy without opioids is the use of ghrelin, a 28-amino acid acylated peptide hormone. However, it has a short half-life and must be delivered via a constant intravenous infusion to have a therapeutic effect. Extend Biosciences' D-VITylation platform technology is truly enabling for small peptide-based therapeutics that are rapidly cleared from the bloodstream by renal filtration. The platform harnesses the naturally long half-life of vitamin D and its dedicated binding protein, VDBP. When the vitamin D molecule is conjugated to a biological therapeutic, it dramatically improves the half-life and bioavailability of the drug. Use of the technology should also allow the drug to be self-administered by subcutaneous injection. This would be of significant benefit to patients. In this project, the team will test the efficacy of EXT405 in a cell-based model of neuropathy as well as in animal models of CIPN and diabetes- induced neuropathy.</p>
</div>
</td>
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<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-36086"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9621873&amp;amp;icde=43814753" target="_blank">2R44DA041912-03</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">COMPLETION OF IND-PACKAGE FOR A NOVEL, NON-NARCOTIC PAINKILLER </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Blue Therapeutics, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Yekkirala, Ajay S </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">CAMBRIDGE, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<tr id="summary16" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-17-302.html" target="_blank">PA-17-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>Opioids like morphine and hydrocodone are generally the most effective therapeutics for treatment of moderate to severe pain. However, their use is limited by serious side effects: tolerance, constipation, respiratory depression, physical dependence, and high addictive potential. Alternative pain relievers with the analgesic potency of conventional opioids, but devoid of narcotic side effects, are an immediate need. The goal of this project is to develop and commercialize an alternative to conventional opioid analgesics with reduced side effects and without the addictive properties common to mu-opioid agonists, targeting a new molecule in the central nervous system. This project will perform the necessary preliminary studies to prepare this new molecule for an investigational new drug application with the FDA.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-33916"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9838457" target="_blank">1R42DA049448-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Reward-based technology to improve opioid use disorder treatment initiation after an ED visit </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Q2I, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BOUDREAUX, EDWIN D </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Rindge, NH </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<tr id="summary17" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R41/R42 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-015.html" target="_blank">RFA-DA-19-015</a>
<br>
<strong>Summary:</strong>
<br>
<p>Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of people with OUD access MAT, and treatment non-adherence is common and associated with poor outcomes. This project aims to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care by enhancing the Opioid Addiction Recovery Support (OARS)—an existing Q2i company technology—with a new evidence-based reward, contingency management (CM) function that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of Suboxone initiation and adherence.</p>
</div>
</td>
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<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34326"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9845104&amp;amp;icde=46470844" target="_blank">1R43DA049650-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Patient-level Risk Identifier Models for a Multifactor Opioid Abuse Risk Assessment Strategy </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">PRINCIPLED STRATEGIES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DuBose, Paul </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">ENCINITAS, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>This project, a partnership with Principled Strategies, will develop innovative, patient-level models for opioid risk identification and integrate them into the SafeUseNow managed care system—an actionable solution for combating prescription drug abuse that currently operates at the prescriber level only. Incorporating patient-level risk identifier models will strengthen an already powerful and demonstrably effective program and constitutes a critical step in generating a first-in-class, multifactor risk assessment strategy that is truly holistic. Using a variety of data sources, advanced analytics, and multiple empirically validated risk identification models, the groundbreaking advancement in SafeUseNow technology will enable health care stakeholders to identify combinations of prescribers, patients, and pharmacies whose behaviors may contribute to prescription drug abuse. This project will work to obtain new datasets for analysis, assess them, and use them to build national patient-level risk models for relevant outcomes, which will enable the development and evaluation of a next-generation prototype for a patient-level version of SafeUseNow.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34711"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9680910&amp;amp;icde=43814317" target="_blank">1R44DA047866-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">NEONATAL OPIOID SCREENING USING APTAMERS AND COMPENSATED INTERFEROMETRY </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Base Pair Biotechnologies, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Jackson, George W </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">PEARLAND, TX </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<tr id="summary19" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Newborn Abstinence Syndrome, which results from maternal opioid drug use prior to birth, is a serious condition that affects approximately 6% of all neonates born today in the U.S. and which is increasing rapidly in incidence because of this epidemic. Availability of a rapid screening test that can be administered at the point of care to all neonates would allow for early intervention, reducing costs of treatment and reducing pain and suffering for this vulnerable and helpless patient population. Providing a platform to accurately monitor actual levels of these drugs and their metabolites in such patients would allow better-controlled use of these pain management treatments, personalized to the needs of the individual neonate, and would reduce the probability of addiction and resulting complications, which include deleterious neurological effects. The purpose of this FastTrack SBIR project is to expand upon preliminary results that a device can sensitively and accurately detect opioids and their primary urinary metabolites in one-microliter urine samples, in less than a minute after sample introduction into the device, and adapt the device into a point-of-care instrument for use in hospitals, clinics, and other venues in which such tests are likely to be deployed.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34826"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9910282" target="_blank">1R43DA050360-01</a>
</span>
<br>
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Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Transcutaneous auricular neurostimulation for neonatal abstinence syndrome </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">SPARK BIOMEDICAL INC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KHODAPARAST, NAVID (contact); JENKINS, DOROTHEA DENISE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Friendswood, TX </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary20" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>As of 2012, an infant with neonatal abstinence syndrome (NAS) was born every 25 minutes in the United States, accounting for more than $1.5 billion in national health care expenditures. These infants frequently require hospital stay in a neonatal intensive care unit (NICU), with an average hospital stay of 25 days at an average treatment cost of $66,000. Treatment of NAS usually follows a multimodal regime based on drug therapy with an oral morphine solution, mostly in combination with a sedative, but there is a need for nonpharmacological approaches. This project will test a transcutaneous auricular neurostimulation device to help NAS babies recover from opioid withdrawal without harmful side effects. The non-invasive, auricular neurostimulation device will be placed around the ear (similar to a hearing aid), and stimulation will be delivered transcutaneously.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34996"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9848085" target="_blank">1R44DA049630-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">TAMADÉ, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">TIEN, CELINE (contact); LUCAS, GALE ; MAHAJAN, AMAN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Pasadena, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary21" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Opioids have been found to be ineffective for chronic lower back pain (CLBP), yet they are still commonly prescribed. TAMADÉ, LLC aims to leverage a novel and validated technology based on virtual reality (VR) to provide therapy to CLBP patients on a daily opioid dosage with an opioid-sparing pain management tool aiming to increase pain management efficacy and decrease health complications. The intervention uses VR to stimulate patients visual, auditory, and haptic fields in order to simultaneously distract and actively engage patients in biofeedback therapy, where patients consciously self-regulate their nervous system by paring down their sympathetic tone through exercises in controlling respiration and heart rate. The study will compare patients receiving the proposed VR-based intervention with a group receiving either just opioids or opioids with sham VR. All groups will receive the same opioid tapering guidelines.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35356"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9911512" target="_blank">1R44DA050357-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">An optimized screening platform for identifying and quantifying biased agonists as drugs for the treatment of Opioid Use Disorder </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">MONTANA MOLECULAR, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">QUINN, ANNE MARIE (contact); HUGHES, THOMAS E </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Bozeman, MT </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary22" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>As the opioid crisis claims more and more lives, there is a need to develop new, safer analgesics. Biased agonists could activate beneficial signaling pathways while avoiding those that cause adverse effects. This project aims to speed the discovery of non-addictive analgesics by providing drug discovery teams with simpler, more robust, more quantitative assays for agonist bias. The goal is to optimize and test new assays for agonist bias at NOP, D3 dopamine, CB1 cannabinoid, and OPRM1 opioid receptors, which couple to both the Gi and ?-arrestin signaling pathway, and create new tools to improve the analysis of structure/activity relationships that can be used in drug discovery and distribute to researchers who are developing new drugs for OUD.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35566"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9849933&amp;amp;icde=43391028" target="_blank">3R44DA044053-02S1</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">emocha Mobile Health, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Seiguer, Sebastian </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Owings Mills, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary23" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-302.html" target="_blank">PA-16-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35871"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9680193&amp;amp;icde=43814379" target="_blank">1R43DA047781-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A NOVEL FAST ACTING NALMEFENE FORMULATION FOR THE PREVENTION AND TREATMENT OF OPIOID OVERDOSE </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">AVIOR, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Vasisht, Niraj </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cary, NC </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary24" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Rescue of victims of opioid overdose is accomplished by treatment with antagonist drugs, such as naloxone, that can reverse the respiratory depression. However, naloxone has serious liver toxicity and a short half-life, and its complete antagonism results in a withdrawal effect. Nalmefene is an FDA-approved opioid derivative that is an antagonist of the MOR and a weak agonist of the k-opioid receptors (KOR). An immediate release intravenous injectable formulation was approved by the FDA in 1995 for opioid overdose; however, the requirement for intravenous administration has limited its clinical use. This project, in partnership with Avior, aims to develop a fast-onset, rapidly-dissolving, mucoadhesive thin film formulation that carries uniformly distributed nalmefene nanoparticles on the surface of the film. This film, produced using Aviors proprietary Speedit™ transmucosal drug delivery technology, rapidly delivers nalmefene when the film is placed in contact with the lower lining of the inner lip. This project will generate non-clinical data to support critical human clinical trials to determine if a transmucosal film can be developed with a rapid onset of action that is required for rescue of opioid overdose patients or taken prophylactically to prevent respiratory depression, to assess whether the effective speed of delivery is sufficient to conduct a human clinical trial.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-33756"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9912548" target="_blank">1R41DA050386-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Prevention of renarcotization from synthetic opioids </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CONSEGNA PHARMA, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">AVERICK, SAADYAH </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Pittsburgh, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary25" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>While the mu opioid receptor (MOR) antagonist naloxone has proven invaluable as an opioid overdose antidote, naloxone suffers from a very short duration of action (half-life is approximately 1 hour) and has been found to be less effective against newer, long-acting opioids, including fentanyl (half-life is approximately 710 hours). This leads to a highly lethal and increasingly prevalent phenomenon known as “renarcotization,” wherein an overdose patient revived with naloxone can re-enter an overdose state from residual fentanyl in the body. Thus, there is a critical need to develop a long-acting MOR antagonist formulation that can address renarcotization by providing multi-hour protection. The goal of this project is to reformulate naloxone using FDA-approved microencapsulation technology into a long-acting injectable (LAI) that can provide 1224 hours of sustained antagonist activity in vivo. It will employ a proprietary Computational Drug Delivery™ software, called ADSR™, to perform in silico formulation optimization as well as to predict its in vitro dissolution and in vivo pharmacokinetic behavior.</p>
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