CAMX.STCAMX.ST

CAMX.ST (CAMX.ST) focuses on psychiatry. Its drug, Buvidal, received a CHMP positive opinion for marketing authorisation on 20 September 2018 for the treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents aged 16 years or over. The reference product for Buvidal is Subutex, which was authorised in Denmark on 14-05-1999 and is marketed by Indivior UK Limited.

In the pivotal Phase 3 study HS-11-421, the primary endpoint was the percentage of urine samples negative for illicit opioids. CAM2038 showed a difference in percentage of negative urine samples of 6.7% compared to control, and 8.7% without imputed data. For heroin users, the treatment difference in percentage of negative urine samples was 13.6% in HS-11-421 and 14.8% overall. In stable patients in study HS-14-499, 84.0% of urine samples were negative for illicit opioids with CAM2038. However, for patients taking prescription opioids, the treatment difference in percentage of negative urine samples was -11.6%.

Regarding safety, 94.8% of healthy volunteers experienced at least one AE with CAM2038. Specific adverse events in healthy volunteers included dizziness (58.5%), nausea (57.8%), headache (33.3%), vomiting (33.3%), and somnolence (25.2%). In patients, 49.5% experienced at least one AE with CAM2038 q1w, and 43.7% with CAM2038 q4w. The mean number of AEs per subject-exposure-year was 6.8 for CAM2038 q1w and 3.3 for CAM2038 q4w. The number of ADRs per subject-exposure-year for CAM2038 was 1.8, compared to 2.5 for SL BPN/NX.