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.
Allowing Orphan Designation Violates the Intent of the Orphan Drug Act, and if Orphan Exclusivity is Granted, No New Buprenorphine OUD Treatment Will Enter the Market until Late 2024Plymouth Meeting, Pa. — April 9, 2019 — Braeburn Inc. has filed a Citizen Petition (CP) with the Food and Drug Administration...
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...
BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUDPlymouth 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...
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...
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...
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...
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...
SOUTH SAN FRANCISCO, CA and PLYMOUTH MEETING, PA – May 30, 2018 – Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) and Braeburn announce that they have agreed to terminate the December 2012 license agreement, which granted Braeburn exclusive rights to commercialize Probuphine in the United States and Canada.Under the terms of the termination...
Plymouth Meeting, Pa. —May 28, 2018 — Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD). The resubmission is in response to the Complete Response Letter issued by the U.S....
Head-to-head study of CAM2038 versus daily sublingual buprenorphine CAM2038 met FDA primary endpoint of non-inferiority (p<0.001) to sublingual buprenorphine CAM2038 demonstrated statistical superiority for the key secondary endpoint (p=0.004) Plymouth Meeting, Pa.—May 14, 2018— Braeburn announced today that the results from its Phase 3 study to evaluate the efficacy and...
