FDA Draft Guidance Promotes Non-Opioid Pain Treatments

Despite recent declines, roughly one in five U.S. adults with chronic pain still receive opioid prescriptions, highlighting the need for safer alternatives. To address this, the U.S. Food and Drug Administration (FDA) issued draft guidance, “Development of Non-Opioid Analgesics for Chronic Pain,” aimed at accelerating the development of effective, lower-risk therapies while reducing opioid reliance.

The guidance outlines strategies for clinical trial design, appropriate patient populations, and meaningful outcomes, including reduced opioid use. It encourages broader indications for multiple chronic pain conditions, innovative trial methods, incorporation of patient-reported outcomes, and expedited regulatory pathways.

This initiative aligns with the SUPPORT Act’s mandate to facilitate non-opioid pain treatment development. As part of its wider strategy against the opioid crisis, the FDA is updating safety labelling for opioids, strengthening enforcement against illegal opioids, and fostering alternative therapies.

15-09-2025