The Food and Drug Administration (FDA) approved a new dosage option for buprenorphine and naloxone sublingual film, which is applied under the tongue as a maintenance treatment for opioid dependence. The treatment was approved through an abbreviated pathway under the Food, Drug, and Cosmetic Act, which may rely on the FDA’s finding that a previously approved drug is safe and effective.
The FDA said there is an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment (MAT) for opioid use disorder. The introduction of new treatment options has the potential to broaden access for patients.
Medication-assisted treatment is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their opioid use disorder cut their risk of death from all causes in half.