On May 23, 2023, the U.S. Food and Drug Administration (FDA) approved an extended-release buprenorphine injection to treat moderate to severe opioid use disorder (OUD). 

The new treatment is available in two formulations – a weekly and monthly injection. The weekly treatment is indicated for patients who have initiated treatment with a single dose of transmucosal buprenorphine or who are already being treated with the buprenorphine, and the monthly treatment is indicated for patients already being treated with buprenorphine.

It is the first and only long-acting buprenorphine injectable available in both weekly and monthly doses. The approval follows FDA’s recent approvals of the first nalmefene hydrochloride nasal spray for the emergency treatment of opioid poisoning in adults and pediatric patients 12 years of age and older and the first over-the-counter naloxone product for known or suspected opioid poisoning. 

Read FDA’s news release here.