ITCI - Intra-Cellular Therapies' Highlights Successful Data From Second Depression Study | Benzinga
Tuesday, Intra-Cellular Therapies Inc (NASDAQ:ITCI) released topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
The company expects to submit a supplemental FDA application in the second half of 2024.
Lumateperone 42 mg, given once daily as adjunctive therapy to antidepressants, met the primary endpoint in Study 502 by demonstrating a statistically significant and clinically meaningful reduction in the Montgomery and Asberg Depression Rating Scale (MADRS) total score compared to placebo ...