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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…
Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot
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 opioid use disorder (OUD). The…
Braeburn Announces Completion of $110 Million Financing
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 that the Company…
Braeburn Pharmaceuticals Welcomes Two New Members to its Board of Directors
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 Kennedy Forum, and co-founder of…