Optimizing Non-Addictive Therapies to Treat Pain
The Research Need
More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. Recent decades have seen an overreliance on opioids for chronic pain despite their poor ability to improve function. This overreliance has contributed to a significant and alarming epidemic of opioid use disorder. Therefore, the development of new therapies as viable alternatives to opioids is urgently needed.
About the Program
This program supports the development and preclinical optimization of safe, effective, and non-addictive small-molecule and biologic therapeutics to treat pain. This research includes optimization and early development of promising small molecules and biologic agents, studies that enable investigational new drug (IND) applications, and culminating in Phase I clinical trials. The goal of the program is to accelerate the development of promising small-molecule and biologic leads toward clinical trials.
Researchers plan to develop novel pain relievers with improved specificity, fewer side effects, and low risks of misuse or dependency. This research will use in vitro assays and animal studies to advance multiple drug candidates. In the long term, the research will advance low-risk treatment options for chronic pain toward clinical development.
To date, through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, NIH has awarded five grants to research institutions and small businesses to support the development of non-addictive small molecules and biologic agents to treat chronic pain.
These research institutions and small businesses will undertake preclinical research and development that will provide new viable alternatives to opioids for treating pain. All of the program’s funded grants use biphasic cooperative agreements. The projects will be milestone driven and involve discovery and developmental research. Only the most promising projects will advance to the second phase of the program directed toward filing IND applications for clinical exploration and commercialization.
Through their awards, the research organizations will develop and optimize non-addictive small molecules and biologic agents for the treatment of chronic pain.
The awardees will conduct research to:
- Develop a novel antibody-drug conjugate for the targeted treatment of nerve pain
- Optimize a targeted central nervous system-penetrant small molecule to treat nerve pain
- Develop selective inhibitors of sodium channels to treat chronic pain
- Optimize a new MNK inhibitor to treat nerve pain
- 4e Therapeutics Inc. – Texas
- Johns Hopkins University – University of Maryland
- Knopp Biosciences, LLC – Pennsylvania
- University of California at Davis – California
- Vanderbilt University – Tennessee
- Weill Medical College of Cornell University – New York
Open Funding Opportunities
Closed Funding Opportunities
Participating NIH Institutes, Centers, and Offices
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Center for Complementary and Integrative Health (NCCIH)
- National Eye Institute (NEI)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institute of Dental and Craniofacial Research (NIDCR)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- National Institute on Drug Abuse (NIDA)
- Office of Research on Women’s Health (ORWH)