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FDA Releases Guidance to Promote Nonopioid Alternatives for Chronic Pain

The FDA's draft guidance aims to increase non-opioid treatment development for chronic pain as opioids are prescribed to 20% of U.S. adults with chronic pain, officials said.

  • On September 11, 2025, the FDA unveiled draft guidelines aimed at promoting effective non-opioid therapies for chronic pain and opened a 60-day period for public feedback.
  • The guidance responds to the 2018 SUPPORT Act and ongoing opioid-related overdose deaths to expand alternatives amid continued opioid reliance.
  • It outlines clinical trial design, patient selection, evaluation of non-opioid drugs’ ability to reduce opioid use, and expedited approval pathways.
  • FDA Commissioner Marty Makary emphasized that the opioid crisis in the United States remains ongoing, highlighting that roughly 20% of adults with chronic pain continue to receive opioid prescriptions.
  • The draft aims to stimulate non-opioid treatment development, building on January 2025 FDA approval of Journavx, the first non-opioid analgesic for acute pain.
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FDA Releases Guidance to Promote Nonopioid Alternatives for Chronic Pain

WEDNESDAY, Sept. 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration released draft guidance to advance safe and effective nonopioid treatment options and reduce risks tied to prescription opioid misuse.

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Newsweek broke the news in United States on Wednesday, September 10, 2025.
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