The FDA issued new draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain” to “accelerate safe and effective non-opioid treatments and to reduce prescription-related opioid misuse.”
Opioids remain commonly prescribed to “about 1 in 5 U.S. adults who live with chronic pain.” The new draft guidance “emphasizes efficient drug development approaches, with specific attention to trial design, appropriate patient populations, and meaningful outcomes.”
The draft guidance specifically outlines regulatory considerations related to “establishing indications for different scopes (e.g., broader categories covering multiple chronic pain conditions versus individual chronic pain indications);” “designing clinical trials that ensure robust evaluation of safety and efficacy, including innovative trial designs and the role of mechanistic understanding of both the drug and the chronic pain conditions being treated;” “evaluating the ability of non-opioid drugs to avoid, reduce, or eliminate opioid use;” and “incorporating statistical principles, patient-reported outcomes, and the use of expedited programs to support drug development in this area.”
The FDA’s “broader strategy to address the opioid crisis includes requiring safety labeling changes for opioid pain drugs (e.g., OxyContin) to better reflect current evidence; enhancing enforcement around the importation and sale of illegal opioid products; and facilitating the development of non-opioid alternatives.”
