U.S. Department of Health & Human Services
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.
Program Details
To date, through the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, NIH has contributed $55.3 million to fund this program through 37 awards.
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