Despite recent declines, opioids remain commonly prescribed to about 1 in 5 U.S. adults who live with chronic pain as effective alternatives are limited. As part of its broader strategy to address the opioid crisis, the U.S. Food and Drug Administration today issued draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain” to accelerate safe and effective non-opioid treatments and to reduce prescription-related opioid misuse.
The new draft guidance emphasizes efficient drug development approaches, with specific attention to trial design, appropriate patient populations, and meaningful outcomes- such as reducing the need for opioid use.
“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.”
The draft guidance outlines regulatory considerations related to:
- Establishing indications for different scopes (e.g., broader categories covering multiple chronic pain conditions versus individual chronic pain indications);
- Designing clinical trials that ensure robust evaluation of safety and efficacy, including innovative trial designs and the role of mechanistic understanding of both the drug and the chronic pain conditions being treated;
- Evaluating the ability of non-opioid drugs to avoid, reduce, or eliminate opioid use; and
- Incorporating statistical principles, patient-reported outcomes, and the use of expedited programs to support drug development in this area.
The guidance fulfills a mandate under Section 3001(b) of the SUPPORT Act, which requires the FDA to issue guidance to help address challenges related to developing non-opioid treatments for pain management.
The FDA’s broader strategy to address the opioid crisis includes requiring safety labeling changes for opioid pain drugs (e.g., OxyContin) to better reflect current evidence; enhancing enforcement around the importation and sale of illegal opioid products; and facilitating the development of non-opioid alternatives.
The FDA is encouraging the public to comment on this draft guidance. Stakeholders have 60 days from the date of publication in the Federal Register to submit feedback electronically at www.regulations.gov or in writing to the Dockets Management Staff, referencing FDA-2025-D-0610 in the Federal Register notice.
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