Development and Optimization of Non-Addictive Therapies to Treat Pain

Overview 

The Research Need 

Overreliance on prescription opioids for chronic pain management has contributed to the opioid overdose crisis. At the same time, millions of Americans do not have adequate relief for pain. New non-addictive therapies for effective pain management as viable alternatives to opioids are urgently needed.  

About the Program 

This program will facilitate research and development in academic and small business settings to evaluate unexplored targets for clinical testing readiness. Research projects will include collaborative, interdisciplinary team science efforts as well as milestone-driven studies with the goal of filing Investigational New Drug (IND) applications with the U.S. Food and Drug Administration for clinical exploration and potential future commercialization. A team-based research framework allows candidate molecules to be tried, validated in various models, prepped for testing in humans, then moved quickly into clinical testing in the HEAL Early Phase Pain Investigation Clinical Network (EPPIC-Net) or other Phase 2 clinical studies.   

The program also features the Non-addictive Analgesic Therapeutics Development program, which provides resources for a variety of activities necessary for early drug development. This includes access to consultants and contract research organizations with resources and extensive experience in the biotech and pharmaceutical industry. Available services include expertise related to medicinal chemistry, manufacturing and formulation, drug metabolism and pharmacokinetics, good laboratory practice toxicology screening, and Phase 1 clinical testing.  

Open Funding Opportunities

2020
HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
Sep 16, 2020
2021
HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
Jun 08, 2021
2022
HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed)
Apr 22, 2022

Program Details

To date, through the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, NIH has funded awards, planning grants, a multidisciplinary team-based study, and milestone-driven biphasic cooperative agreements to research institutions and small businesses to support the development of non-addictive small molecules and biologic agents for the treatment of chronic pain. 

Research Examples

Through their awards, the research organizations will develop and optimize non-addictive small molecules and biologic agents for the treatment of chronic pain.  

Currently funded projects in this program include:  

  • Optimizing the properties of an approved multiple sclerosis drug, monomethyl fumarate, to reduce side effects by limiting its availability in pain-related regions in the central nervous system  
  • Developing a new pain treatment using injected human bone marrow cells that can form and repair skeletal tissues and control nervous and immune system activity 
  • Optimizing an experimental cancer drug, an MNK inhibitor, for neuropathic pain by restricting entry into the brain  
  • Synthesizing peripherally active cannabinoid CB1 receptor agonists as pain treatments  
  • Constructing stem-cell loaded microgels to treat disk-related low back pain  

  • 4e Therapeutics Inc. — Texas   
  • Cedars-Sinai Medical Center — California   
  • Centrexion Therapeutics — Massachusetts    
  • Cleveland Clinic Lerner College of Medicine — Ohio 
  • Hillhurst Biopharmaceuticals, Inc. — California 
  • Holobiome, Inc. — Massachusetts   
  • Johns Hopkins University — Maryland   
  • Knopp Biosciences, LLC — Pennsylvania   
  • Marine Biological Laboratory, Woods Hole — Massachusetts    
  • Massachusetts General Hospital — Massachusetts    
  • St. Louis College of Pharmacy — Missouri    
  • Texas A&M Health Science Center — Texas   
  • University of Arizona — Arizona 
  • University of California, Davis — California   
  • University of Miami School of Medicine — Florida   
  • University of New Mexico Health Sciences Center — New Mexico   
  • University of Texas MD Anderson Cancer Center — Texas 
  • University of Texas Medical Branch — Texas   
  • Vanderbilt University — Tennessee 
  • Virginia Commonwealth University — Virginia  

Funded Projects

2022
A First-in-Class, Mechanism-Guided, Cell-Based Therapy for Complex Regional Pain Syndrome
Sep 14, 2022
2022
Development of Pathology-Activated Drugs for Treatment of Neuropathic Pain
Sep 14, 2022
2022
Oral N2O Therapy in Treating Acute Vaso-Occlusive Pain in Sickle Cell Disease
Jul 07, 2022
2022
Inhibiting RIPK1 with Necrostatin-1 for Safe and Effective Pain Treatment
Jul 07, 2022
2022
Novel mGlu5 Negative Allosteric Modulators as First-in-Class Non-Addictive Analgesic Therapeutic
Jul 07, 2022

Closed Funding Opportunities

2019
HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed)
Sep 25, 2019
2019
Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)
Sep 25, 2019