Otsuka Holdings Co., Ltd. — Rexulti FDA Review (NDA205422, ORIG 1, 2015)
Otsuka Holdings Co., Ltd. · 2015 · FDA Review (openFDA) · company profile →
Report summary
This FDA medical review evaluates Otsuka's New Drug Application for brexpiprazole (Rexulti) for adjunctive treatment of Major Depressive Disorder (MDD) and treatment of Schizophrenia. The review details the regulatory timeline, clinical pharmacology, and extensive clinical trial data. For schizophrenia, brexpiprazole 2 mg/day and 4 mg/day demonstrated superior efficacy over placebo. For MDD, one Phase 3 trial showed significant efficacy as adjunctive treatment, while another did not meet its primary endpoint. Safety assessments covered adverse events, including akathisia, metabolic changes, and weight gain, across short-term and long-term studies. The drug's pharmacokinetic properties, drug-drug interactions, and lack of abuse potential were also analyzed. The report concludes with a comprehensive assessment of the drug's efficacy and safety profile for both indications.
Key findings — cited to the page
| Irritability leading to discontinuation of IMP (all brexpiprazole group, schizophrenia) | 0.2% | · p.132 |
| Severe irritability (all brexpiprazole group, short-term schizophrenia trials) | 0.2% | · p.140 |
| Severe irritability (placebo group, short-term schizophrenia trials) | 0.4% | · p.140 |
| Application Number | 205422 | · p.2 |
| Total number of investigators identified (sub-I) | 241 | 331-09-222 · p.225 |
| Number of investigators with disclosable financial interests/arrangements | 0 | 331-10-227 · p.227 |
| Number of investigators with significant payments of other sorts | 1 | 331-10-242 · p.236 |
| Trade Name | Rexulti | · p.2 |
| Total number of investigators identified (PI) | 95 | 331-10-227 · p.227 |
| Indication | Treatment of Schizophrenia | · p.2 |
| Total number of investigators identified (sub-I) | 517 | 331-10-227 · p.227 |
| Intended Population | Adults | · p.2 |
Source: Otsuka Holdings Co., Ltd. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →