Johnson & Johnson — Xeplion EMA EPAR public assessment report (EMEA/H/C/002105, 2011)
Johnson & Johnson · 2011 · EMA EPAR public assessment report · company profile →
Report summary
This EMA EPAR summarizes the assessment of Xeplion (paliperidone palmitate) for adult schizophrenia. It details the product's chemical quality, non-clinical pharmacology (serotonin and dopamine antagonism, D2 receptor effects, hyperprolactinemia, cardiac effects), and toxicology (injection site reactions, carcinogenicity). Pharmacokinetics, including absorption and distribution, are also covered. Extensive clinical trials (short-term, long-term, placebo-controlled, non-inferiority against Risperdal Consta) demonstrated Xeplion's efficacy in improving PANSS scores and responder rates. The safety profile, consistent with oral paliperidone/risperidone, showed common adverse events like insomnia, headache, injection site pain, metabolic changes, and elevated prolactin. The CHMP recommended marketing authorization for maintenance treatment.
Key findings — cited to the page
| PANSS total score change from baseline (LS mean difference) | -8.6 | PSY-3001 · p.89 |
| PSP score change from baseline (LS mean difference) | 5.3 | PSY-3001 · p.89 |
| Trial duration | 372 days | PSY-3002 · p.90 |
| Relapse rate | 34.0 % | PSY-3001 · p.94 |
| CGI-S score change from baseline (LS mean difference) | -0.2 | PSY-3008 · p.85 |
| Subjects experiencing recurrence (%) | 9.6 % | PSY-3001 · p.88 |
| Subjects experiencing recurrence (%) | 34.0 % | PSY-3001 · p.88 |
| Time to recurrence (p-value) | <0.0001 | PSY-3001 · p.88 |
| Subjects experiencing recurrence (%) | 17.6 % | PSY-3001 · p.88 |
| Subjects experiencing recurrence (%) | 47.8 % | PSY-3001 · p.88 |
| Time to recurrence (p-value) | <0.0001 | PSY-3001 · p.89 |
| CGI-S score change from baseline (p-value) | <0.0001 | PSY-3001 · p.89 |
Source: Johnson & Johnson ↗ · 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 →