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Braeburn Announces Sponsorship of Mobilize Recovery’s Cross-Country Bus Tour
(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 from substance use disorder, supporting…
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
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) in patients who have…
Braeburn’s BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder
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 by a healthcare…
Braeburn Applauds Passage of Significant Advancements in the Treatment of Opioid Use Disorder
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 reinforces the depth and…
FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
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 and Drug Administration (FDA)….
Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
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 Letter issued by the FDA…