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  Plymouth Meeting, Pa.—June 25, 2024—Braeburn Inc. announces the publication of a post hoc analysis in the Journal of the American Medical Association (JAMA) Network Open. The analysis evaluated data in patients with evidence of fentanyl use from the Phase 3 Clinical Efficacy and Safety trial comparing BRIXADI (buprenorphine) extended-release injection...

  (PLYMOUTH MEETING, PA – April 18, 2024) – Braeburn Inc. is thrilled to announce its sponsorship of Mobilize Recovery Across America 2024, Mobilize Recovery’s cross-country bus tour in September, National Addiction and Mental Health Recovery Month, and continuing into October 2024. This collaboration underscores Braeburn's unwavering commitment to celebrating recovery...

  BRIXADI will be available through a restricted distribution program via the BRIXADI REMS Program and is administered only by a healthcare provider.  Plymouth Meeting, Pa.—September 5, 2023—Braeburn announces that BRIXADI (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD)...

  BRIXADI is the first and only long-acting buprenorphine injectable with both weekly and monthly doses.  Patients currently on a transmucosal buprenorphine-containing product can be switched to an equivalent dose of BRIXADI Weekly or Monthly.  BRIXADI will be available through a restricted distribution program via the BRIXADI REMS Program and is administered only...

  Plymouth Meeting, Pa.—December 23, 2022—The recently passed Senate Amendment to H.R. 2617 – Consolidated Appropriations Act, 2023 - includes significant advances in the treatment of opioid use disorder by expanding access to treatment and eliminating policies that created barriers and contributed to stigmatization of the disease. “The passage of H.R. 2617...

Prescription Drug User Fee Act (PDUFA) action date set for May 23, 2023.  Plymouth Meeting, Pa.—December 8, 2022—Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injections for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food...

  Plymouth Meeting, Pa.—November 23, 2022—Braeburn announces that the company has resubmitted to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder. The resubmission is in response to a Complete Response...

  Plymouth Meeting, Pa.—September 24, 2021—Braeburn announces that Joshua M. Cohen, MD, MPH, FAHS has joined the company as Chief Medical Officer. Dr. Cohen will play a critical role within Braeburn’s leadership team overseeing the medical affairs and research and development functions as the Company continues to grow. Dr. Cohen brings extensive...

  Prescription Drug User Fee Act (PDUFA) action date set for December 15, 2021. Plymouth Meeting, Pa. – June 26, 2021 – Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted...

  Plymouth Meeting, Pa. – June 15, 2021 – Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was resubmitted to the U.S. Food and Drug Administration (FDA). The resubmission is in response to...

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