Braeburn Pharmaceuticals News & Media

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....

14 May Braeburn Announces Publication of Positive Phase 3 Results For Long-Acting Buprenorphine For Treatment Of Opioid Use Disorder in JAMA Internal Medicine

Posted at 16:17h in Press Release

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...

12 Apr Braeburn Launches Brave Action

Posted at 16:12h in Press Release

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...

21 Jan Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot

Posted at 16:06h in Press Release

Princeton, N.J.—January 21, 2018 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with...

11 Jan Braeburn Announces Completion of $110 Million Financing

Posted at 16:03h in Press Release

Proceeds to finance investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD) Addiction treatment innovator builds investor syndicate that includes leading healthcare and mutual fund investors to help advance commercialization of CAM2038 Princeton, N.J.— January 10, 2018 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced...

12 Dec Braeburn Pharmaceuticals Welcomes Two New Members to its Board of Directors

Posted at 16:00h in Press Release

Princeton, N.J.—December 12, 2017 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced the appointment of two new members to its Board of Directors, Jeffrey Berkowitz, J.D., former Executive Vice President of UnitedHealth Group/Optum and CEO of Optum International, and Patrick J. Kennedy, former U.S. Representative of Rhode Island, founder of The...

01 Nov Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder

Posted at 15:56h in Press Release

Recommendation based on review of clinical data comprising a broad, real-world opioid use disorder (OUD) population including patients who had concomitant use of other non-opioid substances of abuse A New Drug Application (NDA) for CAM2038 is under FDA priority review with a Prescription Drug User Fee Act (PDUFA) target date of...

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