FDA Guides Development of Non-Opioid Treatments for Chronic Pain to Tackle Opioid Crisis

The U.S. Food and Drug Administration (FDA) has issued new draft guidance aimed at accelerating the development and approval of safe and effective nonopioid therapies for managing chronic pain. This initiative seeks to provide clinicians with alternative treatment options and reduce reliance on opioids, which are frequently prescribed yet carry significant risks of dependence and misuse.

The ongoing opioid epidemic underscores the need for such alternatives, as about 20% of U.S. adults with chronic pain are prescribed opioids. FDA Commissioner Marty Makary stressed that, despite progress, America’s opioid crisis persists. He emphasized that the new guidance would streamline regulatory pathways, making it easier for innovators to bring novel nonopioid drugs to market, ultimately benefiting millions of Americans suffering from chronic pain.

This draft guidance details considerations for defining appropriate indications — whether broad or condition-specific — and highlights the importance of designing innovative, rigorous clinical trials. These trials focus on outcomes that can demonstrate the potential of nonopioids to lessen or replace opioid use, utilizing advanced statistical methods, patient-reported outcomes, and expedited development pathways.

The FDA also plans to update safety labels for existing opioid medications and intensify enforcement against illegal opioid sales and imports. The agency welcomes public comments on the draft guidance, with a 60-day window starting September 11, 2025.

By adopting these measures, the FDA aims to support safer pain management options, decrease opioid dependence, and address the root causes of the ongoing opioid crisis.