Intra-Cellular recently submitted a sNDA to the U.S. FDA for CAPLYTA for MDD

Intra-Cellular (ITCI) Therapies announced that it has recently submitted a supplemental New Drug Application, sNDA, to the U.S. Food and Drug Administration, FDA, for CAPLYTA for the treatment of Major Depressive Disorder, MDD, in adults, as adjunctive therapy to antidepressants. “MDD is a highly prevalent condition with a significant need for efficacious, safe, and well-tolerated medicines, as more than half of patients do not adequately respond to an antidepressant alone,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. “Given CAPLYTA’s efficacy and safety profile, we believe CAPLYTA can become a first-choice treatment for the adjunctive treatment of MDD pending FDA approval, and we look forward to working with the FDA during this review process.”