Accord S L U — Zubsolv EMA EPAR public assessment report (EMEA/H/C/004407, 2017)
Accord S L U · 2017 · EMA EPAR public assessment report
Report summary
This report details the marketing authorization for Zubsolv (buprenorphine/naloxone) in the EU for opioid dependence. A hybrid product, Zubsolv offers improved bioavailability, faster disintegration, and taste masking compared to the reference product, Suboxone. While higher doses showed bioequivalence to Suboxone, lower Zubsolv doses resulted in reduced buprenorphine and naloxone exposure. Clinical trials demonstrated Zubsolv's non-inferiority to Suboxone in some efficacy endpoints, and its safety profile was consistent with Suboxone. The CHMP recommended marketing authorization for adults and adolescents over 15, noting the naloxone component deters intravenous misuse.
Key findings — cited to the page
| Retention in treatment (difference vs Suboxone) | 0.5% | OX219-006 · US · p.32 |
| Retention in treatment | 92.6% | OX219-006 · US · p.32 |
| Retention in treatment | 83.0% | OX219-006 · US · p.32 |
| Retention in treatment | 82.5% | OX219-006 · US · p.32 |
| Marketing authorisation application submission date | 3 October 2016 | Zubsolv · European Union · p.6 |
| Retention in treatment | 93.9% | OX219-006 · US · p.32 |
| CHMP positive opinion date | 14 September 2017 | Zubsolv · European Union · p.8 |
| Adverse events in healthy subjects (vomiting) | 10.6% | · p.35 |
| Adverse events in healthy subjects (headache) | 10.4% | · p.35 |
| Subutex first approval date | 1996 | Subutex · France · p.9 |
| Suboxone first approval date | 2006 | Suboxone · EU · p.9 |
| Retention in treatment (difference vs buprenorphine) | 1.3% | OX219-006 · US · p.32 |
Source: Accord S L U ↗ · 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 →