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
This report summarizes the development program for brexpiprazole (RXULTI) in adolescents with schizophrenia. A pivotal Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled trial (Study 331-10-234) demonstrated statistically significant improvement in PANSS Total Score for brexpiprazole compared to placebo at Week 6, particularly in patients aged 15 and older. Secondary endpoints also showed numerical improvements. Safety findings were consistent with the adult profile, with no new signals and a lower incidence of drug-related adverse events compared to aripiprazole. The program also included an open-label dose escalation trial, an open-label long-term safety trial, and an extrapolation study to support maintenance of effect.
Key findings — cited to the page
| Aripiprazole discontinuation rate | 4.9 % | Study 331-10-234 · p.8 |
| Placebo discontinuation rate | 11.5 % | Study 331-10-234 · p.8 |
| Deaths | 0 | Study 331-10-234 · p.8 |
| Incidence of extrapyramidal symptoms | 1.8 % | · p.28 |
| Incidence of extrapyramidal symptoms | 1.0 % | · p.28 |
| Incidence of extrapyramidal symptoms | 0.0 % | · p.28 |
| Incidence of headache | 4.5 % | · p.28 |
| Incidence of headache | 3.9 % | · p.28 |
| Incidence of headache | 1.0 % | · p.28 |
| Incidence of sedation | 1.8 % | · p.28 |
| Incidence of sedation | 3.9 % | · p.28 |
| Study completion date | 03 April 2023 | 331-10-234 (Study 2, PIP EMEA-001185-PIP01-11-M08) · p.30 |
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 →