FDA Unveils Strategies for Non-Addictive Alternatives to Opioids

The U.S. Food and Drug Administration (FDA) this week unveiled new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and decreasing exposure to opioids. The agenda issued draft guidance to provide recommendations to companies developing non-opioid analgesics for acute pain lasting up to 30 days. The new guidance supports the HHS Overdose Prevention Strategy which focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.

The draft guidance identifies the FDA’s current thinking about various aspects of non-opioid analgesic drug development for acute pain. The FDA is accepting public comments on the draft guidance for industry until April 11, 2022.

Additional information is available here.