FDA Releases Guidance to Promote Nonopioid Alternatives for Chronic Pain

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The U.S. Food and Drug Administration released draft guidance to advance safe and effective nonopioid treatment options and reduce risks tied to prescription opioid misuse.

“America’s opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways. Physicians need more alternatives to opioid medications for patients suffering from chronic pain,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “FDA can help by providing clear guidance like this, which makes regulatory pathways more predictable for innovators and drug developers, enabling effective, lower-risk therapies to quickly reach the millions of Americans living with chronic pain.”

According to the FDA, opioids are commonly prescribed to about one in five U.S. adults living with chronic pain. This is mainly due to a lack of effective alternatives. The agency’s draft guidance underscores more efficient pathways for drug development, with attention to trial structure, patient selection, and clinically meaningful results, including decreased opioid dependence.

The draft guidance outlines regulatory considerations for defining appropriate indications (e.g., broad, multicondition indications compared with narrow, condition-specific ones), designing rigorous and innovative clinical trials, assessing the potential of nonopioids to reduce opioid use, and applying statistical methods, patient-reported outcomes, and expedited pathways to advance development.

The FDA’s comprehensive opioid crisis response also includes mandating evidence-based safety label revisions for opioid analgesics (e.g., OxyContin) and tightening enforcement on illegal opioid imports and sales.

The FDA is encouraging the public to comment on the draft guideline. The window for comment is 60 days from Sept. 11, 2025, the date of publication.

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Source: HealthDay

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