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Press Releases

23 Dec

Posted at 15:34h in Press Release

  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...

08 Dec

Posted at 17:00h in Press Release

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...

23 Nov

Posted at 15:31h in Press Release

  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...

24 Sep

Posted at 09:27h in Press Release

  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...

26 Jun

Posted at 09:59h in Press Release

  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...

15 Jun

Posted at 17:00h in Press Release

  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...

10 Dec

Posted at 13:38h in Press Release

Plymouth Meeting, Pa. – December 10, 2020 – Braeburn announces that a tribunal appointed by the ICC International Court of Arbitration decided that Braeburn did not materially breach its license agreement with Camurus for the development and commercialization of an extended-release buprenorphine subcutaneous injection product. As a result of this...

02 Dec

Posted at 08:30h in Press Release

  Plymouth Meeting, Pa. — December 2, 2020 — Braeburn announces that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for the treatment of moderate to severe opioid use disorder....

15 Sep

Posted at 09:45h in Press Release

Plymouth Meeting, Pa. —September 15, 2020—Braeburn announces that it has appointed Brian Hirsch as General Counsel and Corporate Secretary. Mr. Hirsch joins Braeburn with more than 20 years of pharmaceutical and legal experience, handling complex legal matters for both branded and generic biopharmaceutical companies. He most recently served as Senior Vice...

01 Jun

Posted at 17:29h in Press Release

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...

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