Press Release

05 Sep BRIXADI® (buprenorphine) Extended-Release Injection for Subcutaneous Use (CIII) is Now Available in the U.S. for the Treatment of Moderate to Severe Opioid Use Disorder

Posted at 07:58h in Press Release

BRIXADI will be available through a restricted distribution program via the BRIXADI REMS Program and is administered only by a...

23 May Braeburn’s BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder

Posted at 14:27h in Press Release

BRIXADI is the first and only long-acting buprenorphine injectable with both weekly and monthly doses. Patients currently on a transmucosal buprenorphine-containing...

23 Dec Braeburn Applauds Passage of Significant Advancements in the Treatment of Opioid Use Disorder

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...

08 Dec FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

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...

23 Nov Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

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...

24 Sep Braeburn Appoints Joshua M. Cohen, MD, MPH, FAHS as Chief Medical Officer

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...

26 Jun FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

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 –...

15 Jun Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

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)...

10 Dec Braeburn Announces Arbitration Determination that It Did Not Materially Breach Its License Agreement with Camurus AB

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...

02 Dec Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

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...

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