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

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 ...

12 Jul Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic Pain

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...

22 Jun Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms

Posted at 15:04h in Press Release

Phase 2 Trial Demonstrates Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms in Adults with Opioid Use Disorder New data set from Phase 2 clinical trial presented at the annual scientific meeting of the College on Problems of Drug Dependence and published online in JAMA Psychiatry. Montreal, Canada, —June 22, 2017...

13 Jun Braeburn and Knight Therapeutics Announce Filing of PROBUPHINE® in Canada

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...

05 Jun Braeburn Pharmaceuticals Names Mike Derkacz as President and CEO

Posted at 17:02h in Press Release

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...

02 May Braeburn and Camurus Announce Positive Top-line Results from CAM2038 Safety Study

Posted at 19:39h in Press Release

Princeton, New Jersey and Lund, Sweden — 2 May 2017 — Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) today announced positive top-line results from a long-term Phase 3 trial supporting the safety and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder. “The positive results...

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