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Braeburn in the News

FDA admits it goofed when granting orphan status to an opioid addiction treatment
STAT, November 8, 2019
Ed Silverman

US FDA Revokes Orphan Drug Designation
Pink Sheet, November 11, 2019
Sue Sutter

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Press Releases

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 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...

Camurus and Braeburn Pharmaceuticals Announce Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic Pain Lund, 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...

Braeburn Pharmaceuticals and Knight Therapeutics Announce Filing of New Drug Submission for PROBUPHINE® in Canada for Opioid Drug Dependence PRINCETON, N.J. and MONTREAL — June 13, 2017 — Braeburn Pharmaceuticals, Inc. (“Braeburn”) and Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, announced today that Knight’s New Drug...

Braeburn Pharmaceuticals Names Mike Derkacz as President and CEO, former Head of CNS and Pain Therapeutics for Teva Pharmaceuticals Braeburn President and CEO, Behshad Sheldon, steps down from Company and Board of Directors – Princeton, New Jersey — June 5, 2017 Braeburn Pharmaceuticals, Inc. (Braeburn) announced today that Mike Derkacz has been...

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