(RTTNews) - Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company specializing in central nervous system (CNS) disorders, announced on Tuesday that it has submitted a supplemental New Drug Application to the FDA for CAPLYTA as adjunctive therapy for adults with Major Depressive Disorder who have not adequately responded to antidepressants. The sNDA submission is based on positive results from Phase 3 Studies 501 and 502, which demonstrated CAPLYTA's robust antidepressant efficacy and favorable safety profile. In the studies, CAPLYTA showed an improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score by 4.9 points in Study 501 and 4.5 points in Study 502, with a significant separation from placebo.
The favorable safety profile of CAPLYTA includes low incidences of metabolic, weight, and movement disorder side effects, positioning it as a potential first-choice treatment for MDD if approved.
Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer at Intra-Cellular Therapies, highlighted the importance of addressing the substantial number of MDD patients who do not respond adequately to standard antidepressants.
The FDA's review of CAPLYTA for MDD adjunctive therapy is a key step in addressing this unmet medical need.
CAPLYTA is already approved as an oral atypical antipsychotic for the treatment of schizophrenia and bipolar I or II disorder, both as monotherapy and adjunctive therapy with lithium or valproate.
The drug carries a boxed warning for elderly patients with dementia-related psychosis due to an increased risk of death.
CAPLYTA brought home net product sales of $175.2 million for Intra-Cellular in the third quarter of 2024, compared to $125.8 million for the same period in 2023, representing a 39% increase.
ITCI closed Monday's trading at $86.03, up 0.44%. In premarket trading today, the stock is up by 4.61% at $90.00
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