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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…
Positive Treatment Results for BRIXADI™ (buprenorphine) Extended-Release Injection in Fentanyl Positive Patients Presented at the 50th Conference of the American Society of Addiction Medicine
Phase 3 post-hoc analyses indicate less fentanyl and overall illicit opioid use for weekly/monthly buprenorphine depots versus daily standard treatment Plymouth Meeting, Pa. — April 6, 2019 — Braeburn Inc. announces positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase 3 study of BRIXADI™ (buprenorphine) extended-release weekly and monthly injections for the treatment of…
Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUD Plymouth Meeting, Pa. — December 23, 2018 — Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg)…
CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe
Plymouth Meeting, PA—September 21, 2018 — Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults age 16 and older with opioid…