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Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder
Plymouth Meeting, Pa. —June 1, 2020 — Braeburn announces that it has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of opioid use disorder (OUD). Once approved, BRIXADI will be the only long-acting injectable buprenorphine that…
FDA Grants Braeburn’s Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020
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…
Braeburn Employees Pledge to Reduce Substance Use Disorder Stigma
Plymouth Meeting, Pa. – October 30, 2019 – As part of an ongoing commitment to reduce the stigma associated with opioid use disorder, Braeburn employees pledged to use non-stigmatizing, person-first language when referring to substance use, substance use disorders, recovery, and other related topics. Braeburn is the first biopharmaceutical company to receive professional training and…
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…
Braeburn Announces Publication of Phase 3 Study Results Showing Long-term Safety and Effectiveness of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder
Individualized treatment with BRIXADI weekly and monthly was well-tolerated and effective, with a high (73.6%) treatment retention of patients throughout the 48-week study period. More than 80% of the patients converted from daily sublingual buprenorphine responded that BRIXADI was “much better” or “slightly better” than their previous treatment. Plymouth Meeting, Pa. – June 4, 2019…
Citizen Petition Calls on FDA to Revoke Orphan Designation for Sublocade
Allowing Orphan Designation Violates the Intent of the Orphan Drug Act, and if Orphan Exclusivity is Granted, No New Buprenorphine OUD Treatment Will Enter the Market until Late 2024 Plymouth Meeting, Pa. — April 9, 2019 — Braeburn Inc. has filed a Citizen Petition (CP) with the Food and Drug Administration (FDA) calling on FDA…