FDA revokes Indivior PLC’s orphan designation for opioid use disorder (OUD)* and prevents an additional five-year block of other monthly buprenorphine depot products for OUD
Plymouth Meeting, Pa. – November 7, 2019 – Braeburn Inc. is pleased to confirm that it will seek, and is eligible for, marketing approval for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of OUD as of December 1, 2020. This follows from today’s decision by the U.S. Food and Drug Administration (FDA) to grant Braeburn’s Citizen Petition (filed in April 2019) and thereby revoke Indivior PLC’s orphan designation for buprenorphine treatment for OUD. By revoking Indivior’s orphan designation, Sublocade™ (buprenorphine extended-release) injection is not eligible for any period of orphan exclusivity.
“On behalf of patients and their families, we are grateful to the FDA for allowing additional treatment options to become available sooner,” said Mike Derkacz, President and CEO of Braeburn. “BRIXADI weekly and monthly have been proven to allow healthcare providers to match a patient’s current treatment regimen, addressing an important unmet patient need.”
In a separate communication to Braeburn in response to the July 2019 U.S. District Court ruling, FDA reaffirmed its previous clinical exclusivity decision blocking BRIXADI from the U.S. market through November 30, 2020.
With the FDA revoking Indivior’s orphan designation, BRIXADI is eligible for marketing approval on November 30, 2020, upon expiration of Sublocade’s clinical exclusivity period.
BRIXADI was tentatively approved by the FDA in December 2018 having met all required efficacy, safety and quality standards, but was ineligible for marketing due to a three-year clinical exclusivity period granted to Sublocade. Following the Tentative Approval, Braeburn filed court proceedings seeking to overturn the decision.
After a court hearing in July 2019, Chief Judge Beryl A. Howell ordered FDA to reconsider Braeburn’s application for Final Approval of BRIXADI, including an expectation that FDA would more clearly define innovation standards and provide clarification regarding earlier FDA exclusivity decisions.
Braeburn separately filed a Citizen Petition with FDA in April 2019 requesting FDA to revoke Indivior’s orphan designation and refuse to grant orphan exclusivity to Sublocade.
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 OUD. 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.
Braeburn is dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid use disorder. Our mission is to advance next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of opioid use disorder faced by patients, healthcare providers, payers and society. For more information about Braeburn, please visit www.braeburnrx.com.
* Indivior PLC was granted orphan-designation for “opiate addiction in opiate users” in 1995. At the time of Indivior’s request for orphan-drug designation, “opiate addiction” was the clinically recognized term. “Opiate addiction” is however no longer a commonly used term in clinical practice and is now termed opioid dependence or opioid use disorder (as referenced in the Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM-IV).
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