Uzedy
Psychiatry· 904 cited findings· 1 source document
What the regulatory reviews say
Uzedy (NDA 213586) is an antipsychotic medication for the treatment of schizophrenia in adults, approved via a 505(b)(2) application on April 28, 2023. The primary endpoint for efficacy, time to impending relapse, was met with a statistically significant difference. In a study involving 543 patients with schizophrenia, the hazard ratio for TV-46000 q1m versus placebo was 0.200 (p-value <0.0001), and for TV-46000 q2m versus placebo was 0.375 (p-value <0.0001). For impending relapse (death, AE, or lack-of-efficacy as events), the hazard ratio for TV-46000 q1m versus placebo was 0.55 (p-value <0.0001), and for TV-46000 q2m versus placebo was 0.673 (p-value 0.0058).
Common adverse reactions include weight gain, dyslipidemia, hyperglycemia, increased prolactin, sedation/somnolence, and extrapyramidal symptoms. Injection site reactions, most commonly pruritus and nodule, occurred in 21% of patients, with 2% discontinuing due to these reactions. A case of priapism was also noted in Study 30072.
Key figures — cited to the source page
| Hazard ratio (TV-46000 q1m vs placebo) for time to impending relapse | 0.200 | Uzedy FDA Review, p.185 |
| p-value (TV-46000 q1m vs placebo) for time to impending relapse | <0.0001 | Uzedy FDA Review, p.185 |
| Hazard ratio (TV-46000 q2m vs placebo) for time to impending relapse | 0.375 | Uzedy FDA Review, p.185 |
| p-value (TV-46000 q2m vs placebo) for time to impending relapse | <0.0001 | Uzedy FDA Review, p.185 |
| Injection site reactions | 21 | Uzedy FDA Review, p.18 |
| Discontinuation due to injection site reactions | 2 | Uzedy FDA Review, p.18 |
| Application Type | 505(b)(2) | Uzedy FDA Review, p.2 |
| Review Completion Date | April 28, 2023 | Uzedy FDA Review, p.2 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.