Buvidal
Psychiatry· 407 cited findings· 1 source document
Company: Camurus
What the regulatory reviews say
Buvidal is indicated for the treatment of opioid dependence in adults and adolescents aged 16 years or over, within a framework of medical, social, and psychological treatment. The CHMP issued a positive opinion for marketing authorisation on 20 September 2018.
The primary endpoint of the pivotal Phase 3 study, which was a randomized, double-blind, double-dummy trial, evaluated the percentage of urine samples negative for illicit opioids. In this study, the difference in percentage of negative urine samples between CAM2038 and the control group was 6.7%. For heroin users, the treatment difference in percentage of negative urine samples was 13.6%. The overall median cumulative percentage of urine samples negative for illicit opioids was 26.7% for CAM2038, compared to 6.7% for SL BPN/NX.
Safety data from healthy volunteers showed that 94.8% experienced at least one adverse event (AE) with CAM2038. Common AEs included dizziness (58.5%), nausea (57.8%), headache (33.3%), vomiting (33.3%), and somnolence (25.2%). The number of AEs per subject-exposure-year was 5.1 for CAM2038 and 7.3 for SL BPN/NX.
Key figures — cited to the source page
| CHMP positive opinion for marketing authorisation | 20 September 2018 | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.8 |
| difference in percentage of negative urine samples (CAM2038 vs control) | 6.7% | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.77 |
| treatment difference in percentage of negative urine samples for heroin users | 13.6% | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.77 |
| overall median cumulative percent urine samples negative for illicit opioids (CAM2038) | 26.7% | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.77 |
| overall median cumulative percent urine samples negative for illicit opioids (SL BPN/NX) | 6.7% | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.77 |
| percentage of healthy volunteers with at least one AE (CAM2038) | 94.8% | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.79 |
| percentage of healthy volunteers with dizziness (CAM2038) | 58.5% | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.79 |
| number of AEs per subject-exposure-year (CAM2038) | 5.1 | Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/, p.80 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.