News & Media Relations

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...

05 Oct Braeburn CEO Participates in U.S. Department of Health and Human Services Secretarial Round Table Discussion on Opioids

Posted at 15:52h in Press Release

Princeton, N.J.—October 5, 2017 — Braeburn Pharmaceuticals, Inc. (Braeburn) today participated in a roundtable discussion at the U.S Department of Health & Human Services (HHS) in Washington, DC led by Assistant Secretary for Mental Health and Substance Abuse, Dr. Elinore F. McCance-Katz, M.D., Ph.D. and including senior HHS officials and...

27 Sep Braeburn Participates in President’s Commission Meeting on Combating Drug Addiction and the Opioid Crisis

Posted at 15:48h in Press Release

Princeton, N.J. — September 27, 2017 — Braeburn Pharmaceuticals, Inc. (Braeburn) today participated in the Third Meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis held in the Eisenhower Executive Office of the President in Washington, DC. Braeburn President and CEO, Mike Derkacz shared the Company’s...

18 Sep FDA Acceptance of NDA for CAM2038 for Opioid Use Disorder

Posted at 15:38h in Press Release

Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder If approved, CAM2038 will provide patients and HCPs with weekly and monthly dosing options for the treatment of opioid use disorder, with the goal of improving treatment adherence...

20 Jul Braeburn and Camurus Announce Submission for CAM2038 for Opioid Use Disorder

Posted at 15:29h in Press Release

Braeburn and Camurus Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder If approved, CAM2038 would provide weekly and monthly dosing options for patients with Opioid Use Disorder Priority Review of the NDA has been applied for which, if granted, would shorten the review process of CAM2038 ...

Media

Press Releases