Rolling submission to FDA started for CAM 2038 (buprenorphine depots) in Opioid Use Disorder- Braeburn Pharmaceuticals and Camurus

Braeburn Pharmaceuticals and Camurus 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 CAM 2038 (buprenorphine depots) to treat Opioid Use Disorder. Braeburn has also applied for Priority Review which, if granted, could shorten the review process of CAM2038 following the FDA's acceptance of the NDA.

The NDA submission for CAM 2038 includes data from a comprehensive global clinical development program, evaluating 944 study participants across seven clinical trials: Four pharmacokinetic (PK) studies of weekly and monthly CAM 2038 in healthy volunteers or patients, including also pharmacodynamic assessments. A Phase II opioid blockade study demonstrating sustained blockade of drug liking and suppression of withdrawal by CAM2038 from the first day of treatment. A 24-week Phase III randomized, double-blind, double-dummy study of CAM2038 against standard daily sublingual buprenorphine and included flexible dosing throughout the study period.

The study met both the primary and key secondary endpoints, showing superiority for CAM2038 versus sublingual buprenorphine for the cumulative distribution function for percentage of illicit opioid-negative urine tests and self-reports. A 48-week Phase III open-label, long-term safety study confirming the safety profile and long-term effectiveness of CAM 2038 in new-to-treatment patients and patients switched from daily buprenorphine.