Posted by Michael Wonder on 23 Jul 2019
U.S. District Court orders FDA to reconsider application for final approval of Brixadi (buprenorphine) extended release injection for the treatment of opioid use disorder
23 July 2019 - The U.S. District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating the U.S. FDA December 2018 exclusivity determination which blocked Brixadi from final approval through 30 November 2020.
Braeburn’s application for final approval of Brixadi is remanded back to FDA for reconsideration “with deliberate speed.”
Chief Judge Beryl A. Howell noted that FDA determined Sublocade’s exclusivity in the broadest sense and failed to demonstrate how Sublocade’s exclusivity was consistent with FDA’s previous decisions. Chief Judge Howell also acknowledged that all parties recognise the national public health crisis and the need for additional treatment options for patients with opioid use disorder.
