The company’s marketing authorization application (MAA) for the investigational, weekly and monthly CAM2038 buprenorphine depots for the treatment of opioid dependence has been fully validated by the European Medicines Agency.
The application, submitted on 26 July 2017, is now under assessment by the Committee for Human Medicinal Products (CHMP).
“The validation of the MAA for CAM2038 represents a significant step towards bringing the first long-acting treatment for opioid dependence to patients and physicians in Europe,” said Fredrik Tiberg, President and CEO at Camurus. “If approved, our weekly and monthly subcutaneous buprenorphine depots could transform the treatment of opioid dependence by improving treatment outcomes and reducing the burdens and risks of daily medication.”
The MAA is supported by a comprehensive clinical program comprising 7 clinical studies, including two Phase 3 studies. A core component of the MAA submission is the positive results from a randomized, double-blind, double-dummy study of weekly and monthly CAM2038 depot injections versus daily treatment with sublingual buprenorphine/naloxone in 428 adult patients with opioid use disorder. The study met the primary endpoint of non-inferiority for mean percentage urine samples negative for illicit opioids. Superiority was demonstrated for the first secondary endpoint of cumulative distribution function for the percentage of urine samples negative for illicit opioids during treatment weeks 4 to 24. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine with the exception for mild-to-moderate injection-site adverse events.
CAM2038 for the treatment of opioid dependence will be reviewed under the centralized procedure for all 28 EU member states, Norway, Lichtenstein and Iceland.