News from braeburn A wide array of domestic and global news stories; news topics include politics/government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle.

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Jul 23, 2019, 09:14 ET U.S. District Court Orders FDA to Reconsider Application for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

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 ...


Jun 04, 2019, 07:06 ET 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

Braeburn Inc. announces the publication of its 48-week, open-label, multi-center, global Phase 3 long-term safety study of once weekly and once...


Apr 09, 2019, 08:29 ET Citizen Petition Calls on FDA to Revoke Orphan Designation for Sublocade

Braeburn Inc. has filed a Citizen Petition (CP) with the Food and Drug Administration (FDA) calling on FDA to protect the integrity and intent of the ...


Apr 06, 2019, 11:59 ET 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

Braeburn Inc. announces positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase 3 study of BRIXADI™ (buprenorphine)...


Dec 23, 2018, 09:00 ET Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder

Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release...


Sep 21, 2018, 07:24 ET CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe

Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use...


Sep 18, 2018, 10:00 ET Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy

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...


Jul 16, 2018, 08:00 ET Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder

Braeburn announces that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26,...


Jun 25, 2018, 08:00 ET Braeburn Appoints Richard Malamut, M.D. as Chief Medical Officer

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...


May 28, 2018, 02:00 ET Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder

Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly...