FDA broadens treatment options for opioid dependence

The Food and Drug Administration Friday approved a new dosage option for buprenorphine and naloxone sublingual film, applied under the tongue as a maintenance treatment for opioid dependence. The medication-assisted treatment was approved through an abbreviated pathway under the Federal Food, Drug, and Cosmetic Act, which may rely on the FDA’s finding that a previously approved drug is safe and effective. “There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder,” said FDA Commissioner Scott Gottlieb, M.D. “The introduction of new treatment options has the potential to broaden access for patients.”