Court Vacates Exclusivity for First Injectable Buprenorphine Product

A federal judge last week ordered the Food and Drug Administration (FDA) to reconsider its decision to grant market exclusivity to the first approved injectable formulation of buprenorphine for opioid dependence.

The order from the U.S. District Court for the District of Columbia granted pharmaceutical manufacturer Braeburn's motion for summary judgment, vacating an exclusivity determination for the injectable buprenorphine manufactured by Indivior and sold as Sublocade. The FDA's exclusivity determination from last December blocked the entry of Braeburn's Brixadi into the market through November 2020.

The FDA approved Sublocade in November 2017 for the treatment of patients with opioid dependence who had been initiated to treatment with daily sublingual buprenorphine.

“We are pleased by the District Court's decision which is an important step toward making Brixadi available to healthcare providers and patients,” Braeburn president and CEO Mike Derkacz said in a news release.

Last month, results of a Phase 3 study of Brixadi involving 227 patients were published in the journal Addiction. The 48-week study found that weekly and monthly individualized treatment with the injectable drug resulted in a 73.6% retention rate in treatment. In addition, more than 80% of participants said their new treatment was much or slightly better than their original sublingual buprenorphine.