Drug maker accuses FDA of hampering its medication for opioid treatment
Washington Post, April 9, 2019
By Paige Winfield Cunningham
Battle brewing over opioid abuse disorder drugs
Philadelphia Business Journal, April 9, 2019
By John George
Braeburn is committed to working with stakeholders and advocacy groups to improve outcomes for patients and their families. Check out our CEO’s testimony at the 43 minute mark.
New Resource For Dedicated Healthcare Professionals Treating Opioid Use DisorderPrinceton, 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...
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...
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 CAM2038Princeton, N.J.— January 10, 2018 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced...
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...
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...
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...
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...
Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use DisorderIf 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...
Braeburn and Camurus Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use DisorderIf 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 ...
Camurus and Braeburn Pharmaceuticals Announce Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic PainLund, Sweden and Princeton, NJ — 12 July 2017 — Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) today announced positive results from a Phase 2 pharmacokinetic study of weekly and monthly buprenorphine...
