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Press Releases

04 Jun Braeburn Announces Publication of Phase 3 Study Results Showing Long-term Safety and Effectiveness of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

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. –...

09 Apr Citizen Petition Calls on FDA to Revoke Orphan Designation for Sublocade

Posted at 08:11h in Press Release

Allowing Orphan Designation Violates the Intent of the Orphan Drug Act, and if Orphan Exclusivity is Granted, No New Buprenorphine OUD Treatment Will Enter the Market until Late 2024 Plymouth Meeting, Pa. — April 9, 2019 — Braeburn Inc. has filed a Citizen Petition (CP) with the Food and Drug Administration...

06 Apr Positive Treatment Results for BRIXADI™ (buprenorphine) Extended-Release Injection in Fentanyl Positive Patients Presented at the 50th Conference of the American Society of Addiction Medicine

Posted at 11:50h in Press Release

Phase 3 post-hoc analyses indicate less fentanyl and overall illicit opioid use for weekly/monthly buprenorphine depots versus daily standard treatment Plymouth Meeting, Pa. — April 6, 2019 — Braeburn Inc. announces positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase 3 study of BRIXADI™ (buprenorphine) extended-release weekly and monthly injections...

23 Dec Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder

Posted at 14:00h in Press Release

BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUD Plymouth Meeting, Pa. — December 23, 2018 — Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly...

21 Sep CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe

Posted at 11:23h in Press Release

Plymouth Meeting, PA—September 21, 2018 — Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults age...

18 Sep Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy

Posted at 10:00h in Press Release

Plymouth Meeting, PA—September 18, 2018 — Braeburn announces positive top-line results for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid therapy. CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for healthcare professional...

16 Jul Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder

Posted at 08:00h in Press Release

If approved, CAM2038 will provide patients and HCPs with flexible-dose weekly and monthly options for the treatment of opioid use disorder, with the goal of improving treatment adherence and reducing the burdens associated with daily medication. Plymouth Meeting, Pa. —July 16, 2018 —Braeburn announces that the U.S. Food and Drug Administration...

25 Jun Braeburn Appoints Richard Malamut, M.D. as Chief Medical Officer

Posted at 14:54h in Press Release

Plymouth Meeting, PA—June 25, 2018—Braeburn announces that Richard Malamut, M.D. has joined the company as Chief Medical Officer. Dr. Malamut brings to Braeburn more than 25 years of pharmaceutical and clinical leadership experience at emerging and leading biopharmaceutical companies. Dr. Malamut will lead a team of clinical and medical professionals that...

30 May Titan Pharmaceuticals and Braeburn Announce Mutual Termination of License Agreement for Probuphine® for Opioid Dependence

Posted at 16:23h in Press Release

SOUTH SAN FRANCISCO, CA and PLYMOUTH MEETING, PA – May 30, 2018 – Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) and Braeburn announce that they have agreed to terminate the December 2012 license agreement, which granted Braeburn exclusive rights to commercialize Probuphine in the United States and Canada. Under the terms of the termination...

28 May Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder

Posted at 16:21h in Press Release

Plymouth Meeting, Pa. —May 28, 2018 — Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD). The resubmission is in response to the Complete Response Letter issued by the U.S....

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