Daily Dose: FDA Approves Buprenorphine Extended-release Injection for Opioid Use Disorder

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On May 24, 2023, we reported on the US Food and Drug Administration (FDA) approval of Brixadi (buprenorphine) extended-release subcutaneous injection for the treatment of moderate-to-severe opioid use disorder (OUD).

The approval

Brixadi is the first long-acting buprenorphine injectable that can be given in weekly doses to patients who have already initiated treatment with a single dose of a transmucosal buprenorphine product or who are already receiving treatment with a transmucosal buprenorphine-containing product, and in monthly doses for patients already being treated with buprenorphine.

The approved doses of Brixadi vary by frequency of use. The weekly doses include 8 mg, 16 mg, 24 mg, and 32 mg, and the monthly doses include 64 mg, 96 mg, and 128 mg. Brixadi will be available through a Risk Evaluation and Mitigation Strategy program and will only be administered by health care providers in a health care setting.

The most common adverse reactions associated with Brixadi included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia, and urinary tract infection.

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