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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).
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.