FDA Clears New Buprenorphine Option to Treat OUD

One day after approving a new opioid overdose reversal nasal spray product, the US Food and Drug Administration (FDA) announced on Tuesday that it has also given its approval for Brixadi, a new extended-release injection for subcutaneous use to treat moderate-to-severe opioid use disorder (OUD).

Developed by Braeburn Inc., the medication is available in 2 formulations: (1) a weekly injection for patients who have started treatment with a single dose of a transmucosal buprenorphine product; or (2) who are already being treated with buprenorphine and a monthly injection for patients already being treated with buprenorphine.

Brixadi is approved at varying doses for both its weekly and monthly formulations, with lower doses that the FDA says may be appropriate for patients who cannot tolerate higher doses of extended-release buprenorphine products currently available. Weekly doses of Brixadi are 8 mg, 16 mg, 24 mg, and 32 mg. Monthly doses are 64 mg, 96 mg, and 128 mg.

Brixadi will be available through a Risk Evaluation and Mitigation Strategy program and administered only by providers in a healthcare setting.

The new medication from Braeburn was approved by the FDA after its safety and efficacy were evaluated in a behavioral pharmacology study assessing the ability of 2 weekly doses of Brixadi to block the subjective effects of opioids, as well as 1 randomized, double-blind, active controlled clinical trial in 428 adults diagnosed with moderate-to-severe OUD.

“Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” FDA Commissioner Robert M. Califf, MD, said in a news release on Tuesday. “The FDA will continue to take the critical steps necessary to pursue efforts that advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA’s Overdose Prevention Framework.”

Reference

FDA approves new buprenorphine treatment option for opioid use disorder. News release. US Food and Drug Administration. May 23, 2023. Accessed May 24, 2023.

Valentino T. New opioid overdose reversal nasal spray receives FDA approval. Addiction Professional. Published online May 23, 2023. Accessed May 24, 2023.