Camurus announces European Medicines Agency validation of CAM2038 Marketing Authorization Application for treatment of opioid dependence
Lund, Sweden — 29 September 2017 — Camurus (NASDAQ STO: CAMX) today announced 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 (EMA). 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.
Weekly and monthly CAM2038 buprenorphine depots comprise a new investigational treatment for opioid dependence. CAM2038 is designed to enable flexible and individualized treatment across treatment phases; from initiation and stabilization to long-term maintenance. Long-acting treatment durations and administration by healthcare professionals ensures medication adherence, while potentially minimizing risks of diversion, misuse and accidental pediatric exposure.
Weekly and monthly CAM2038 buprenorphine depots are provided ready for use in prefilled syringes for administered as a small volume subcutaneous injection (less than 0.65 mL). The suite of products includes weekly doses ranging from 8 mg to 32 mg and monthly doses from 64 mg to 160 mg.
Camurus is a Swedish research-based pharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the proprietary FluidCrystal® drug delivery technologies and an extensive R&D expertise. Camurus’ clinical pipeline includes products for treatment of cancer, endocrine diseases, pain and addiction, developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker “CAMX”. For more information, visit www.camurus.com.
For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 92
The information was submitted for publication at 08.00 am CET on 29 September 2017.