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

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

Plymouth Meeting, Pa. – July 23, 2019 – The U.S. District Court for the District of Columbia (District Court) granted Braeburn’s motion for summary judgment, vacating the U.S. Food and Drug Administration’s (FDA) December 2018 exclusivity determination which blocked 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.”

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 recognize the national public health crisis and the need for additional treatment options for patients with opioid use disorder.

“We are pleased by the District Court’s decision which is an important step toward making BRIXADI available to healthcare providers and patients,” said Mike Derkacz, President and CEO of Braeburn. “We look forward to working expeditiously with FDA to get BRIXADI on the market as soon as possible.”

Separately, Braeburn continues to await the decision from FDA regarding its Citizen Petition requesting that FDA refuse to grant orphan drug exclusivity to Sublocade on the basis that opioid use disorder is not a bona fide orphan disease with over two million Americans diagnosed.

A link to Chief Judge Howell’s determination can be found here.

About BRIXADI (buprenorphine) Extended-Release Injection for SC Use (CIII)

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. BRIXADI is tentatively approved by FDA for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI will be administered only by healthcare providers in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support.

About Braeburn

Braeburn is dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. Our mission is to advance next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, healthcare providers, payers and society. For more information about Braeburn, please visit www.braeburnrx.com.

For additional information:

Colleen Saltmer: csaltmer@braeburnrx.com



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