Braeburn has requested final approval from the U.S. Food and Drug Administration for Brixadi, an injectable form of buprenorphine with weekly and monthly formulations.
Brixadi was tentatively approved by the FDA for treatment of moderate to severe opioid use disorder in December 2018, but is not eligible for marketing in the U.S. until Dec. 1, 2020.
Brixadi was studied against sublingual buprenorphine/naloxone in an efficacy and safety trial, and it was also found to be effective in reducing opioid withdrawal and cravings, maintaining low withdrawal and craving scores in the trial. Results of the trial were published in JAMA Internal Medicine.
Braeburn said in a news release that it expects a review cycle resulting in final approval of Brixadi by the FDA on Dec. 1.