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FDA Approves Extended-Release Injection, Brixadi, for Opioid Use Disorder

May 30, 2023


The U.S. Food and Drug Administration has approved Brixadi (buprenorphine) extended-release injection to treat moderate-to-severe opioid use disorder.

Brixadi is approved for both weekly (8 mg, 16 mg, 24 mg, 32 mg) and monthly (64 mg, 96 mg, 128 mg) subcutaneous injectable formulations, including lower doses that may be appropriate for people not able to tolerate higher doses of extended-release buprenorphine. Furthermore, the approved lower strength weekly formulation offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence. Brixadi can only be administered by health care providers in a health care setting through a Risk Evaluation and Mitigation Strategy program.