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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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...
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 ...
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...
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...
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...
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...
