FDA Issues New Draft Guidance to Advance Non-Opioid Treatments for Chronic Pain

Although opioid prescribing has declined in recent years, opioids remain a common treatment option for chronic pain—still used by nearly 1 in 5 U.S. adults living with long-term pain. The ongoing reliance highlights the urgent need for safer, effective alternatives.

As part of its national strategy to combat the opioid crisis, the U.S. Food and Drug Administration (FDA) released new draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain.” The document aims to accelerate the development of safe non-opioid pain treatments while reducing the risk of prescription opioid misuse.

A Push Toward Innovation

The draft guidance encourages drug developers to explore more efficient and innovative trial designs, identify appropriate patient populations, and focus on meaningful outcomes—such as reducing or eliminating the need for opioids.

“America’s opioid crisis is far from over. We must continue to find new solutions for this longstanding challenge,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Patients living with chronic pain deserve alternatives to opioids. By providing clear regulatory guidance, FDA helps innovators develop effective, lower-risk therapies and bring them to the millions of Americans who need them.”

Key Focus Areas in the Draft Guidance

The FDA’s proposal provides drug developers with a framework for regulatory approval of non-opioid medications, covering:

  • Scope of Indications – Whether a drug should target broad categories of chronic pain conditions or focus on specific pain syndromes.

  • Clinical Trial Design – Encouraging robust safety and efficacy evaluations, innovative trial structures, and deeper mechanistic understanding of both pain conditions and the therapies being tested.

  • Measuring Opioid Impact – Assessing a drug’s ability to reduce, replace, or prevent opioid use.

  • Patient-Centered Outcomes – Incorporating patient-reported outcomes, sound statistical methods, and expedited approval programs where appropriate.

This initiative fulfills a mandate under Section 3001(b) of the SUPPORT Act, which directs the FDA to issue guidance on advancing non-opioid treatments for pain management.

A Broader Federal Strategy Against the Opioid Crisis

Beyond this new guidance, the FDA’s broader opioid strategy includes:

  • Requiring updated safety labeling for opioid pain medications (such as OxyContin) to reflect the latest evidence on risks.

  • Strengthening enforcement against the importation and sale of illegal opioids, including dangerous synthetic drugs like FYL and XYL-laced products.

  • Facilitating research and development of non-opioid therapies to give providers and patients more choices.

Public Input Encouraged

The FDA is actively seeking public and stakeholder feedback on this draft guidance. Comments can be submitted within 60 days of publication in the Federal Register, either electronically at www.regulations.gov or in writing to the Dockets Management Staff. Submissions should reference FDA-2025-D-0610.

Source: FDA

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