Intra-Cellular announces results for lumateperone as adjunctive therapy in MDD

Intra-Cellular Therapies announced positive topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This trial, in conjunction with our previously reported positive Phase 3 study, Study 501, forms the basis for our lumateperone sNDA for the adjunctive treatment of MDD. We expect to submit this sNDA to the U.S. Food and Drug Administration FDA n the second half of 2024.”We are confident that the efficacy results from Studies 501 and 502, along with the favorable safety and tolerability profiles from these studies, will make lumateperone a drug of choice for patients suffering with MDD who are having an inadequate response to antidepressant therapy,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. …These results, further support our vision for CAPLYTA to become a leading option for patients and providers across mood disorders.”…Supplemental NDA sNDA submission for the adjunctive treatment of major depressive disorder MDD anticipated in the second half of 2024…