Opioid Use Disorder: Braeburn’s New Drug Application (NDA) for BRIXADI™, our extended release buprenorphine medication developed for subcutaneous weekly and monthly dosing, has received Tentative Approval from FDA. With Tentative Approval, the FDA has concluded that, based on information available in the submitted NDA, BRIXADI met all required quality, safety and efficacy standards necessary for approval but is not eligible for marketing in the U.S. because of exclusivity considerations.
Pipeline
Chronic Pain: Braeburn is also investigating CAM2038 in opioid tolerant patients with chronic pain as part of its ongoing pivotal Phase III program.
Learn more about the results of CAM2038’s clinical trials.