Don’t let the maker of a buprenorphine drug abuse the Orphan Drug Act
STAT, May 28, 2019
By Diane Dorman
In Midst Of Opioid Crisis, FDA May Block New Addiction Drug From Market
NPR, May 24, 2019
By Alison Kodjak
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.
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...
Phase 2 Trial Demonstrates Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms in Adults with Opioid Use DisorderNew 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 DependencePRINCETON, 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 PharmaceuticalsBraeburn President and CEO, Behshad Sheldon, steps down from Company and Board of Directors – Princeton, New Jersey — June 5, 2017Braeburn 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...
