FDA Approves First Monthly Injection to Treat Opioid Addiction

The Food and Drug Administration has approved the first ever buprenorphine injection for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients.

The new injection is the medication-assisted treatment (MAT) option, Sublocade, which provides a new treatment option for patients in recovery from opioid addiction who may value the benefits of a once-monthly injection, compared to other forms of buprenorphine treatment.

MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine or naltrexone) with counseling and other behavioral therapies to help provide effective treatment and long-term recovery in patients with OUD.

“Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety. Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” said FDA Commissioner Scott Gottlieb, M.D.

Improving access to prevention, treatment and recovery services, including the full range of medication-assisted treatments, is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis.