Camurus — Buvidal EMA EPAR public assessment report (EMEA/H/C/004651, 2018)
Camurus · 2018 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Camurus AB's Buvidal (buprenorphine), a prolonged-release solution for opioid dependence in adults and adolescents. Buvidal, a hybrid medicinal product referencing Subutex, utilizes FluidCrystal® technology for weekly or monthly administration. Pharmaceutical development, including formulation, manufacturing, and quality control, is detailed. Pharmacological studies confirm buprenorphine's activity and compare Buvidal's bioavailability to Subutex. A pivotal Phase III study (HS-11-421) demonstrated Buvidal's non-inferiority, and in some cases superiority, to sublingual buprenorphine/naloxone in reducing illicit opioid use, particularly for heroin users. While efficacy and retention rates were comparable, Buvidal showed some advantages in craving reduction. The safety profile was generally similar, though injection site reactions were more frequent with Buvidal. The report also addresses safety concerns in special populations, drug-drug interactions, overdose, withdrawal, and abuse, emphasizing the unmet need for long-acting buprenorphine formulations.
Key findings — cited to the page
| percentage of urine samples negative for illicit opioids | 35.1% | HS-11-421 · p.77 |
| percentage of urine samples negative for illicit opioids | 28.4% | HS-11-421 · p.77 |
| Reference product authorisation date | 14-05-1999 | Subutex · Denmark · p.6 |
| Indication | Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over. | Buvidal · p.116 |
| Reference product marketing authorisation holder | Indivior UK Limited | Subutex · p.6 |
| Pivotal Phase 3 study design | randomized, double-blind, double-dummy | HS-11-421 · p.11 |
| Primary endpoint of pivotal Phase 3 study | percentage of urine samples negative for illicit opioids | HS-11-421 · p.11 |
| Accelerated assessment request outcome | not agreed | · p.12 |
| CHMP Scientific Advice date | 22 October 2015 | · p.7 |
| Reference product name | Subutex | · p.6 |
| CHMP positive opinion for marketing authorisation | 20 September 2018 | Buvidal · p.8 |
| difference in percentage of negative urine samples (CAM2038 vs control) | 6.7% | HS-11-421 · p.77 |
Source: Camurus ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →