Media

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

Media inquiries: csaltmer@braeburnrx.com

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.

Press Releases

11 Jan

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

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

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

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

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

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...

12 Jul

Posted at 15:22h in Press Release

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...

13 Jun

Posted at 19:39h in Press Release

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...

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