Teva Pharmaceutical Industries Limited — Uzedy FDA Review (NDA213586, ORIG 1, 2023)
Teva Pharmaceutical Industries Limited · 2023 · FDA Review (openFDA) · company profile →
Report summary
Teva Pharmaceutical Industries Limited's NDA for Uzedy (risperidone extended-release injectable suspension) for adult schizophrenia initially faced a complete response due to clinical trial protocol deviations and data integrity concerns. Subsequent third-party audits and sensitivity analyses, accounting for dosing errors, confirmed Uzedy's effectiveness in preventing relapse, with statistically significant differences compared to placebo. Its safety profile, including common adverse events like weight gain, dyslipidemia, hyperglycemia, increased prolactin, sedation, and extrapyramidal symptoms, is largely consistent with existing risperidone formulations, with injection site reactions being formulation-specific. Pharmacokinetic and exposure-response analyses supported the proposed dosing regimens. Despite initial data issues, the FDA ultimately recommended approval, citing substantial evidence of effectiveness.
Key findings — cited to the page
| Number of subjects in TV-46000-CNS-30072 study | 596 | TV-46000-CNS-30072 · p.240 |
| Trial Phase | phase 1 | · p.160 |
| Number of patients with schizophrenia in Study TV-46000-CNS-30072 | 543 patients | TV-46000-CNS-30072 · p.16 |
| Number of subjects in TV-46000-SAD-10055 study | 96 | TV-46000-SAD-10055 · p.239 |
| Number of subjects in PopPK analysis | 694 | · p.239 |
| Number of studies included in PopPK analysis | 5 | · p.239 |
| Number of subjects in RISPE1ZG15EU study | 55 | RISPE1ZG15EU · p.239 |
| Estimated volume of distribution (V) for risperidone | 66.3 L | · p.250 |
| Estimated absorption rate constant route 1 (KA1) for risperidone | 0.00063 /hr | · p.250 |
| Estimated absorption rate constant route 2 (KA2) for risperidone | 0.00041 /hr | · p.250 |
| Total number of investigators identified | 591 | TV-46000-CNS-30072 · p.221 |
| Number of subjects in Stage 2 of TV-46000-CNS-30078 study | 300 | TV-46000-CNS-30078 · p.240 |
Source: Teva Pharmaceutical Industries Limited ↗ · 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 →