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Positive Treatment Results for BRIXADI™ (buprenorphine) Extended-Release Injection in Fentanyl Positive Patients Presented at the 50th Conference of the American Society of Addiction Medicine
Phase 3 post-hoc analyses indicate less fentanyl and overall illicit opioid use for weekly/monthly buprenorphine depots versus daily standard treatment Plymouth Meeting, Pa. — April 6, 2019 — Braeburn Inc. announces positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase 3 study of BRIXADI™ (buprenorphine) extended-release weekly and monthly injections for the treatment of…
Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUD Plymouth Meeting, Pa. — December 23, 2018 — Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg)…
CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe
Plymouth Meeting, PA—September 21, 2018 — Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults age 16 and older with opioid…
Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy
Plymouth Meeting, PA—September 18, 2018 — Braeburn announces positive top-line results for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid therapy. CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for healthcare professional (HCP) administration. The study met…
Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder
If approved, CAM2038 will provide patients and HCPs with flexible-dose weekly and monthly options for the treatment of opioid use disorder, with the goal of improving treatment adherence and reducing the burdens associated with daily medication. Plymouth Meeting, Pa. —July 16, 2018 —Braeburn announces that the U.S. Food and Drug Administration (FDA) has assigned a…
Braeburn Appoints Richard Malamut, M.D. as Chief Medical Officer
Plymouth Meeting, PA—June 25, 2018—Braeburn announces that Richard Malamut, M.D. has joined the company as Chief Medical Officer. Dr. Malamut brings to Braeburn more than 25 years of pharmaceutical and clinical leadership experience at emerging and leading biopharmaceutical companies. Dr. Malamut will lead a team of clinical and medical professionals that are committed to Braeburn’s…