Braeburn today announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD).
Braeburn President and CEO, Mike Derkacz shared the Company’s commitment to expanding opioid use disorder (OUD) treatment options through cutting edge research and improving access to Medication Assisted Therapy (MAT), in alignment with the HHS five-point strategy to reverse the trajectory of the epidemic.
Braeburn today participated in the Third Meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Braeburn President and CEO, Mike Derkacz shared the Company’s progress in advancing new, long-acting treatment options to help address the escalating disease burden of addiction faced by Americans, including the development of injectable treatments for opioid use disorder (OUD) to potentially minimize the risk of diversion and abuse.
Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
Braeburn Pharmaceuticals and Camurus today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of the companies’ weekly and monthly buprenorphine depots (CAM2038) to treat Opioid Use Disorder.
Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) today announced positive results from a Phase 2 pharmacokinetic study of weekly and monthly buprenorphine (CAM2038) depots in opioid dependent patients with moderate-to-severe non-cancer chronic pain.
Phase 2 Trial Demonstrates Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms in Adults with Opioid Use Disorder
Braeburn Pharmaceuticals, Inc. and Knight Therapeutics Inc., a leading Canadian specialty pharmaceutical company, announced today that Knight’s New Drug Submission has been accepted for review by Health Canada for Probuphine® implant for the treatment of opioid drug dependence.
Braeburn Pharmaceuticals Names Mike Derkacz as President and CEO, former Head of CNS and Pain Therapeutics for Teva Pharmaceuticals
Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Results from Long-term Phase 3 Safety Study of CAM2038.