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FDA Grants Braeburn's Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020
Thu November 7, 2019 9:14 PM|PR Newswire
PR Newswire
PLYMOUTH MEETING, Pa., Nov. 7, 2019 /PRNewswire/ -- 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 re-affirmed 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.
Background
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 p