Posted by Michael Wonder on 12 Dec 2024
Intra-Cellular Therapies submits supplemental new drug application to FDA for Caplyta (lumateperone) for the treatment of major depressive disorder as adjunctive therapy
3 December 2024 - The sNDA submission is based on positive results from Studies 501 and 502 demonstrating Caplyta’s robust anti-depressant efficacy and favourable safety and tolerability profile.
Intra-Cellular Therapies announced that it has recently submitted a supplemental new drug application to the US FDA for Caplyta (lumateperone) for the treatment of major depressive disorder in adults, as adjunctive therapy to anti-depressants.
