Press Release July 26, 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

Goodwin’s FDA Litigation and Appellate Litigation teams represented Braeburn in a successful lawsuit against the U.S. Food and Drug Administration (FDA). The U.S. District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating the FDA December 2018 exclusivity determination which blocked Braeburn’s new drug product BRIXADI 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.”

Braeburn is dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid use disorder. BRIXADI is an extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection used for the treatment of moderate to severe opioid use disorder.

Chief Judge Beryl A. Howell noted that FDA determined the competing product’s exclusivity in the broadest sense and failed to demonstrate how that exclusivity was consistent with 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.

The Goodwin team included partners William Jay, Sarah Frederick, Brian Burgess, and David Zimmer, and associates Gerard Cedrone and Christopher Herbert. Co-counsel was Scott Lassman of Lassman Law+Policy.

For more details, read the press release and the court’s opinion.