FDA Approves Braeburn’s Application For Brixadi, New Buprenorphine Injectable Treatment Option For Opioid Use Disorder

The U.S. Food and Drug Administration (FDA) approved Braeburn’s application for Brixadi, a long-acting buprenorphine injectable for opioid use disorder (OUD) with both weekly and monthly doses. Brixadi is an extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection used for the treatment of moderate to severe OUD. It will available in the U.S. in September 2023, through a restricted distribution program via the Brixadi REMS Program and must be administered only by a health care professional.

Brixadi is the first and only weekly and monthly subcutaneous injection for moderate to . . .