Intra-Cellular Therapies Inc (NASDAQ:ITCI) unveiled on Tuesday topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
Topline results from the second Phase 3 study, Study 502, are anticipated late in the second quarter of this year.
Caplyta (lumateperone) is a once-daily pill proven to deliver significant symptom relief from bipolar I and bipolar II depression.
“We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, ...