How is the FDA promoting nonopioid alternatives for chronic pain?

The U.S. Food and Drug Administration has introduced draft guidance aimed at promoting safe and effective nonopioid treatments to mitigate the risks associated with prescription opioid misuse. Despite ongoing efforts, the opioid crisis in America persists, necessitating new strategies to address the issue. FDA Commissioner Marty Makary emphasized the need for more alternatives to opioids for chronic pain management, highlighting the role of the FDA in providing clear regulatory guidance to facilitate the development of innovative, lower-risk therapies. Currently, opioids are prescribed to approximately 20% of U.S. adults with chronic pain, largely due to the lack of effective alternatives. The FDA’s draft guidance aims to streamline drug development by focusing on trial design, patient selection, and clinically significant outcomes, such as reduced opioid dependence. It also addresses regulatory considerations for defining appropriate indications, designing innovative clinical trials, and utilizing statistical methods and patient-reported outcomes. Additionally, the FDA is enhancing its response to the opioid crisis by mandating evidence-based safety label revisions for opioid analgesics and strengthening enforcement against illegal opioid imports and sales. The public is invited to comment on the draft guidance within 60 days of its publication on September 11, 2025.