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Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder
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 (FDA) has assigned a…
Braeburn Appoints Richard Malamut, M.D. as Chief Medical Officer
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 are committed to Braeburn’s…
Titan Pharmaceuticals and Braeburn Announce Mutual Termination of License Agreement for Probuphine® for Opioid Dependence
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 agreement, Titan will regain…
Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder
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. Food and Drug Administration in…
Braeburn Announces Publication of Positive Phase 3 Results For Long-Acting Buprenorphine For Treatment Of Opioid Use Disorder in JAMA Internal Medicine
Head-to-head study of CAM2038 versus daily sublingual buprenorphine CAM2038 met FDA primary endpoint of non-inferiority (p<0.001) to sublingual buprenorphine CAM2038 demonstrated statistical superiority for the key secondary endpoint (p=0.004) Plymouth Meeting, Pa.—May 14, 2018— Braeburn announced today that the results from its Phase 3 study to evaluate the efficacy and safety of CAM2038, an…
Braeburn Launches Brave Action
New Resource For Dedicated Healthcare Professionals Treating Opioid Use Disorder Princeton, N.J.—April 12, 2018 — Braeburn, as part of its overall efforts to improve the lives of patients with Opioid Use Disorder (OUD), announced today the launch of Brave Action, a new disease-focused resource to support the many healthcare providers on the front lines of…