FDA ordered to reconsider Braeburn's application for final approval of Brixadi

The US District Court for the District of Columbia (District Court) granted Braeburn Pharmaceutical’s (Nasdaq: BBRX) motion for summary judgment, vacating the US Food and Drug Administration’s December 2018 exclusivity determination which blocked Brixadi (buprenorphine) extended  release injection from final approval through November 30, 2020.

Braeburn’s application for final approval of Brixadi is remanded back to FDA for reconsideration “with deliberate speed.”

Chief Judge Beryl Howell noted that the FDA determined Indivior’s (LSE: INDV) Sublocade (buprenorphine/naloxone) exclusivity in the broadest sense and failed to demonstrate how Sublocade’s exclusivity was consistent with the FDA’s previous decisions. Chief Judge Howell also acknowledged that all parties recognize the national public health crisis and the need for additional treatment options for patients with opioid use disorder.