June 21, 2023

Brixadi Approved for Opioid Use Disorder

The FDA has approved Brixadi (buprenorphine) extended-release injections for subcutaneous use to treat moderate-to-severe opioid use disorder (OUD).

Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine.

The weekly doses are available in 8 mg, 16 mg, 24 mg, and 32 mg, while the monthly doses are 64 mg, 96 mg, and 128 mg. The approved weekly formulation in various lower strengths offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence.

The FDA considers buprenorphine to be a safe and effective medication for the treatment of OUD. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), patients receiving medication for their OUD cut their risk of death from all causes in half.

As opioid medications are commonly seen in workers’ compensation claims, and even when used as indicated, opioids can cause physical dependence and addiction. As workers’ comp patients may require buprenorphine to address OUD, Brixadi may appear in workers’ comp claims.

Adverse reactions include injection-site pain, headache, constipation, nausea, redness or itchy skin at the injection site, insomnia, and urinary tract infections.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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