The U.S. Food and Drug Administration (FDA) today announced the release of draft guidance designed to promote the development of safe and effective nonopioid treatments for chronic pain, aiming to reduce reliance on prescription opioids and address the risks of 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,” said FDA Commissioner Marty Makary, M.D., M.P.H.
“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, nearly one in five U.S. adults with chronic pain is prescribed opioids, largely due to limited treatment alternatives. The new draft guidance emphasizes more efficient drug development pathways, focusing on trial design, patient selection, and clinically meaningful outcomes, including the ability of nonopioid therapies to reduce opioid use.
Key provisions in the guidance include:
- Defining appropriate treatment indications (broad versus condition-specific).
- Designing rigorous, innovative clinical trials.
- Assessing the potential of nonopioids to reduce opioid reliance.
- Applying advanced statistical methods and patient-reported outcomes.
- Utilizing expedited review pathways to accelerate development.
This initiative builds on the FDA’s broader opioid crisis response, which includes mandatory safety labeling revisions for opioid analgesics, such as OxyContin, and stronger enforcement against illegal opioid imports and sales.
The FDA is seeking public comment on the draft guidance for 60 days following its publication on September 11, 2025.
About the FDA
The U.S. Food and Drug Administration protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, medical devices, food supply, cosmetics, and products that emit radiation.
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