Opioid misuse continues being a challenge in the United States, with it being prescribed to about 1 in 5 U.S adults who struggle with chronic pain & which is due to limited non-opioid alternatives. To address this, the FDA has released draft guidance, “Development of Non-Opioid Analgesics for Chronic Pain,” aimed at speeding the development of safe, effective non-opioid options and helping reduce the risks of opioid misuse.

The FDA has published draft guidance to inspire the development of non-opioid treatments for chronic pain, as required under the SUPPORT Act. The guidance addresses several key areas: defining treatment indications for broad or specific chronic pain conditions, designing clinical trials that are both rigorous and innovative, and assessing whether new drugs can reduce or replace opioid use. It also focuses on the importance of including patient-reported outcomes, applying sound statistical principles, and using expedited pathways to speed development of promising therapies.

This initiative forms part of the FDA’s broader strategy to combat the opioid crisis. In addition to supporting safer alternatives, the agency is updating safety labels on opioid medicines to reflect the latest evidence, strengthening implementation against the sale and import of illegal opioids, and advancing new non-opioid options for patients. Together, these measures are designed to reduce misuse and improve care for millions living with chronic pain.

Learn more: FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse