Otsuka Holdings Co., Ltd. — Rxulti EMA EPAR variation assessment report (EMEA/H/C/003841, 2018)
Otsuka Holdings Co., Ltd. · 2018 · EMA EPAR variation assessment report · company profile →
Report summary
Otsuka Holdings Co., Ltd. submitted a Type II variation for Rxulti (brexpiprazole) to update its Summary of Product Characteristics. This update is based on final safety and efficacy data from Trial 331-10-236, a completed Phase 3, long-term, open-label study in adolescents (13-17 years old) with schizophrenia. The study primarily aimed to characterize long-term safety, with efficacy as a secondary endpoint. It demonstrated consistent improvements in PANSS total, positive, and negative subscales, and CGI scores over 24 months, with a high response rate. Common adverse events included weight gain, somnolence, and akathisia. Crucially, no new safety signals were identified, and the overall benefit-risk balance for Rxulti remains positive.
Key findings — cited to the page
| Incidence of irritability | 2.0% | 331-10-236 · p.21 |
| total incidence of irritability | 2.0 % | · p.28 |
| incidence of irritability in long-term adult schizophrenia trials | 0.8 % | · p.28 |
| Trial duration | 24 months | 331-10-236 · p.4 |
| Number of subjects in trial 331-10-236 (interim analysis) | 288 subjects | 331-10-236 · p.4 |
| Number of subjects in trial 331-10-236 (final report) | 295 adolescents | 331-10-236 · p.4 |
| Brexpiprazole approval for schizophrenia in adults | 2018 | Brexpiprazole · EU · p.3 |
| Trial phase | Phase 3 | 331-10-236 · p.3 |
| Trial design | Long-term, Multicenter, Open-label | 331-10-236 · p.3 |
| Patient age range | 13-17 years old | 331-10-236 · p.3 |
| Variation application submission date | 20 October 2025 | · p.3 |
| Brexpiprazole approval for schizophrenia in adolescents | Mar 2025 | Brexpiprazole · EU · p.3 |
Source: Otsuka Holdings Co., Ltd. ↗ · 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 →