The US Food and Drug Administration has introduced draft guidance aimed at promoting nonopioid treatment options for chronic pain, addressing the ongoing opioid crisis by reducing dependence on prescription opioids. FDA Commissioner Marty Makary emphasized the need for more alternatives to opioids, highlighting the agency’s role in providing clear guidance to facilitate the development of effective and lower-risk therapies for chronic pain sufferers. Currently, opioids are prescribed to approximately 20% of US adults with chronic pain, largely due to the lack of effective alternatives. The draft guidance focuses on streamlining drug development, improving trial designs, and assessing nonopioids’ potential to decrease opioid use. Additionally, the FDA is revising safety labels for opioid analgesics and tightening regulations on illegal opioid activities. Public comments on the draft guidance are open for 60 days following its publication on September 11, 2025.
Is the FDA Promoting Nonopioid Alternatives for Chronic Pain?
