Credit: US Food and Drug Adminstration

The US Food and Drug Administration (FDA) has approved buprenorphine (Brixadi) extended-release injection for subcutaneous use for the treatment of patients with moderate to severe opioid use disorder (OUD).¹

Buprenorphine is available either in a weekly injection formulation that can be used in patients who have begun treatment with a single dose of a transmucosal buprenorphine product or those who are already being treated with buprenorphine and a monthly formulation for patients already being treated with buprenorphine.

Both the weekly and monthly formulations are approved at varying doses, including lower doses that could be more appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available. The weekly doses are available in 8 mg, 16 mg, 24 mg, and 32 mg, while the monthly doses are available in 64 mg, 96 mg, and 128 mg.

The approval is based on the results of a behavioral pharmacology study assessing the drug in 2 weekly doses to block the subjective effects of opioids, as well as a randomized, double-blind, active-controlled clinical trial involving 428 adults with moderate-to-severe OUD.

For the safety data, the most common adverse reactions in the buprenorphine were injection-site pain, headache , constipation, nausea, injection-site erythema, itchy skin at the injection site, insomnia, and urinary tract infections.

"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," said FDA Commissioner Robert M. Califf, MD, in a statement. "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."

References:

Administration, U. S. F. and D. (2023, May 23). FDA approves new buprenorphine treatment option for opioid use disorder. PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/fda-approves-new-buprenorphine-treatment-option-for-opioid-use-disorder-301832651.html