Media

Braeburn in the News

FDA admits it goofed when granting orphan status to an opioid addiction treatment
STAT, November 8, 2019
Ed Silverman

US FDA Revokes Orphan Drug Designation
Pink Sheet, November 11, 2019
Sue Sutter

Media inquiries: csaltmer@braeburnrx.com

Braeburn is committed to working with stakeholders and advocacy groups to improve outcomes for patients and their families. Check out our CEO’s testimony at the 43 minute mark.

Press Releases

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...

07 Nov

Posted at 21:08h in Press Release

  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...

02 Oct

Posted at 11:02h in Press Release

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...

23 Jul

Posted at 08:52h in Press Release

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...

04 Jun

Posted at 06:50h in Press Release

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. –...

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