Court orders FDA to reconsider final approval of Brixadi

A December 2018 decision by the Food and Drug Administration (FDA) to block the final approval of a product from Braeburn Pharmaceuticals for the treatment of opioid use disorder has been vacated.

The U.S. District Court of the District of Columbia granted summary judgment to Braeburn, the makers of Brixadi, meaning the FDA must now reconsider the drug “with deliberate speed,” according to the ruling.

"We are pleased by the District Court's decision, which is an important step toward making Brixadi available to health care providers and patients," Braeburn President and CEO Mike Derkacz said in a press release. "We look forward to working expeditiously with the FDA to get Brixadi on the market as soon as possible."

The court's ruling stated that while the weekly-prescribed version of Brixadi is able to be submitted for final approval, the monthly version will not be available to be approved until the end of a three-year right to exclusivity by the company Indivior. That three-year period ends on Nov. 30, 2020. 

Chief Judge Beryl A. Howell stated that the FDA failed to demonstrate how Indivior's product Sublocade's exclusivity was consistent with the FDA’s previous decisions, according to the press release.

Braeburn is also awaiting an FDA decision regarding the Citizen Petition on the exclusivity of Sublocade because opioid use disorder is not a bona fide orphan disease.