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Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
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 January 19, 2018 Additionally,…
Braeburn CEO Participates in U.S. Department of Health and Human Services Secretarial Round Table Discussion on Opioids
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 industry leaders. The meeting focused…
Braeburn Participates in President’s Commission Meeting on Combating Drug Addiction and the Opioid Crisis
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 progress in advancing new, long-acting…
FDA Acceptance of NDA for CAM2038 for Opioid Use Disorder
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 and reducing the burdens associated…
Braeburn and Camurus Announce Submission for CAM2038 for Opioid Use Disorder
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 Robust clinical dossier supports potential…
Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic Pain
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 (CAM2038) depots in opioid…