
Washington, D.C. – Millions of Americans living with chronic pain may soon see more treatment options, as the U.S. Food and Drug Administration (FDA) issued new draft guidance this week to accelerate the development of non-opioid therapies.
According to the FDA, opioids remain prescribed to about 1 in 5 adults with chronic pain, despite recent declines in use and continued concerns over misuse. The new guidance, titled “Development of Non-Opioid Analgesics for Chronic Pain,” outlines steps to speed safer alternatives and reduce dependence on opioids.
The draft guidance highlights trial design, patient populations, and measurable outcomes such as reduced opioid reliance. “America’s opioid crisis is not over. We must stay vigilant,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Physicians need more alternatives, and FDA can help make regulatory pathways clearer for drug developers so patients have access to lower-risk therapies.”
Key provisions address establishing broader or condition-specific indications, designing robust clinical trials, incorporating patient-reported outcomes, and leveraging expedited review programs. The effort fulfills a mandate under the SUPPORT Act requiring FDA to guide non-opioid pain drug development.
This move is part of the FDA’s larger opioid strategy, which also includes updating opioid drug safety labels, cracking down on illegal opioid sales, and supporting innovation in pain management.
The public has 60 days from publication in the Federal Register to submit comments on the draft guidance at www.regulations.gov, referencing docket FDA-2025-D-0610.
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