Braeburn said this week that it won tentative FDA approval for its Brixadi extended-release weekly and monthly buprenorphine injections.
The company’s product is designed for the treatment of moderate to severe opioid use disorder in people who have already started treatment with buprenorphine.
The FDA acknowledged that Braeburn met all required quality, safety and efficacy standards with Brixadi – but the product isn’t eligible for marketing in the U.S., the agency said, due to “exclusivity considerations.”
The FDA can’t give full approval to Braeburn’s Brixadi until the exclusivity period for Indivior’s Sublocade treatment expires in 2020, according to the Philadelphia Business Journal.
Brixadi features Braeburn’s FluidCrystal injection depot tech, which combines a low volume lipid-based liquid and a dissolved active ingredient. After the solution is injected, it transitions into a nanostructured liquid-crystalline gel, enabling slow release of the drug at a continuous rate over a weekly or monthly period.
“With both weekly and monthly doses, Brixadi supports current treatment guidelines that recommend frequent office visits, especially early in recovery when patients may discontinue treatment and there is a high risk of overdose,” president & CEO Mike Derkacz said in prepared remarks.
“Braeburn, and our partner Camurus, are currently reviewing FDA’s tentative approval of Brixadi and remain committed to taking appropriate actions with the goal of providing patients with OUD access to this much-needed, innovative long-acting treatment option as soon as possible,” Derkacz added.