Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose

Overview 

The Research Need 

Three medications – methadone, buprenorphine, and naltrexone – are approved by the U.S. Food and Drug Administration for the treatment of opioid use disorder. In addition, lofexidine is approved to treat opioid withdrawal, but not for all populations. There are limitations to the use of these medications; they are underused; and they may not be as effective against more potent synthetic opioids that are driving record-high numbers of overdoses. More effective and flexible treatment options are needed to treat opioid use disorder, as are new therapeutic strategies for stimulants and drug combinations. 

About the Program 

The goal of this program is to identify and develop innovative technologies and high-throughput approaches for small molecules, biologics, and other therapeutic approaches to prevent and treat opioid use disorder, as well as to reverse opioid-induced respiratory depression. Research supports the development of new medications and treatment approaches with increased efficacy, fewer side effects, and that require fewer visits to a healthcare facility.  

In addition, the program includes a focus on the development of therapeutic options for use by vulnerable populations, such as pregnant women and newborns experiencing opioid withdrawal. The program also supports development of medications for the treatment of stimulant use disorders due to the increase in use of (and overdose from) these drugs. 

Program Details

To date, through the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, NIH has awarded grants to fund the optimization of new therapies to prevent and treat opioid use disorder. The institutions with these awards are undertaking preclinical research and clinical trials to determine the safety and efficacy of these new treatments.

Research Examples

Research examples supported by this program include: 

  • Developing technology to control the release of opioid medications in the body to treat opioid use disorder or prevent relapse  
  • Developing medications to manage opioid withdrawal, reduce cravings, and lower the risk of a relapse in people receiving treatment for opioid use disorder 
  • Developing opioid vaccines to reduce the risk of an opioid overdose and to treat opioid use disorder 
  • Optimizing oral, injectable, and implantable, long-acting medications to treat opioid use disorder 
  • Developing medical devices to detect an opioid overdose and automatically administer life-saving medications 
  • Developing medications that can prevent or reverse opioid-induced respiratory depression 
  • Developing medications for the treatment of stimulant use disorder, withdrawal, and overdose; co-occurring opioid and stimulant use disorders; or reversing concurrent opioid and stimulant overdose 

  • Adynxx, Inc. – California 
  • Artys Biotech, LLC – Pennsylvania 
  • Astellas Pharma Global Development, Inc. – Illinois 
  • Astraea Therapeutics, LLC – California 
  • AstraZeneca Pharmaceuticals – Delaware 
  • Baylor College of Medicine – Texas 
  • BiocorRx, Inc. – California 
  • Biomedical Research Institute of New Mexico – New Mexico 
  • Boston University Medical Campus – Massachusetts 
  • Butler Hospital – Rhode Island 
  • Cerevel Therapeutics, LLC – Massachusetts 
  • Cessation Therapeutics, LLC – California  
  • Delpor, Inc. – California 
  • Duke University – North Carolina 
  • Eicosis, LLC – California 
  • Emergent Product Development Gaithersburg, Inc. – Maryland 
  • Emory University – Georgia 
  • Ensysce Biosciences, Inc. – California 
  • Epiodyne, Inc. – California 
  • Hager Biosciences, Inc. – Pennsylvania 
  • Henry M. Jackson Foundation for the Advancement of Military Medicine – Maryland 
  • Icahn School of Medicine at Mount Sinai – New York 
  • Indiana University-Purdue University at Indianapolis – Indiana 
  • Indivior – Virginia 
  • Insys Development Company – Arizona 
  • Intervexion Therapeutics, LLC – Arkansas 
  • Intra-Cellular Therapies, Inc. – New York 
  • Johns Hopkins University – Maryland 
  • Kinoxis Therapeutics, Pty LTD – Victoria, Australia 
  • Libero Pharma Limited – Edinburgh, United Kingdon 
  • Lohocla Research Corporation – Colorado 
  • Lyndra Therapeutics, Inc. – Massachusetts 
  • Massachusetts General Hospital – Massachusetts 
  • McLean Hospital – Massachusetts 
  • Mebias Discovery, LLC – Pennsylvania 
  • Medical University of South Carolina – South Carolina 
  • New York State Psychiatric Institute – New York 
  • Nirsum Laboratories, Inc. – New York 
  • Northeastern University – Massachusetts 
  • Otsuka Pharmaceutical Development & Commercialization, Inc.  – New Jersey  
  • Pennsylvania State University Hershey Medical Center – Pennsylvania 
  • Phoenix Pharmalabs, Inc. – Utah 
  • Pocket Naloxone Corporation – Maryland 
  • Purdue University – Indiana 
  • Salk Institute for Biological Sciences – California 
  • Sanford Burnham Prebys Medical Discovery Institute – California 
  • Sloan-Kettering Institute – New York 
  • The Drug Delivery Company, LLC – Maryland 
  • The University of Texas Medical Branch at Galveston – Texas 
  • Titan Pharmaceuticals, Inc. – California 
  • University of Arizona – Arizona 
  • University of British Columbia – British Columbia, Canada 
  • University of California, Davis – California 
  • University of California, Los Angeles – California 
  • University of Colorado, Denver – Colorado 
  • University of Florida – Florida 
  • University of Illinois at Chicago – Illinois 
  • University of Kentucky Research Foundation – Kentucky 
  • University of Minnesota– Minnesota 
  • University of New Mexico Health Sciences Center – New Mexico 
  • University of Pennsylvania – Pennsylvania 
  • University of Texas Health Science Center at San Antonio – Texas 
  • University of Texas Health Science Center – Texas 
  • University of Washington – Washington 
  • USWM, LLC – Kentucky 
  • Virginia Commonwealth University – Virginia 
  • Virginia Polytechnic Institute and State University – Virginia 
  • Washington State University – Washington 
  • Wayne State University – Michigan 
  • West Virginia University – West Virginia 
  • Yale University – Connecticut

Funded Projects

2022
Phase 1 and 2 Studies of Sublingual Dexmedetomidine, an Alpha 2 Adrenergic Agonist, for Treating Opioid Withdrawal
Oct 01, 2022
2022
The Development of Delta Opioid Receptor Agonists for the Treatment of Opioid Withdrawal Associated Behaviors
Sep 30, 2022
2022
IND-Enabling Program for a Long-Acting Anti-Methamphetamine Monoclonal Antibody for Treating Methamphetamine Use Disorder
Sep 19, 2022
2022
Development of a Monoclonal Antibody to Reverse Overdose from Fentanyl and Its Analogs: From Manufacturing to Clinical Trials
Sep 19, 2022
2022
Development of PPL-138, a Novel Mixed NOP/Mu Partial Agonist for Treatment of Cocaine Use Disorder
Sep 19, 2022

Closed Funding Opportunities

2019
Behavioral & Integrative Treatment Development Program (R01 Clinical Trial Optional)
Sep 25, 2019
2019
NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
Sep 25, 2019
2019
NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
Sep 25, 2019
2019
NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
Sep 25, 2019
2019
NIH Research Project Grant (Parent R01 Clinical Trial Required)
Sep 25, 2019

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