Core Insights - Johnson & Johnson submitted a supplemental New Drug Application (sNDA) to the FDA for CAPLYTA® based on long-term Phase 3 data showing a 63% reduction in relapse risk for schizophrenia patients compared to placebo [1][2] - CAPLYTA® is the first and only FDA-approved treatment for both schizophrenia and bipolar I and II depression, enhancing Johnson & Johnson's portfolio of schizophrenia therapies [1][3] Company Overview - Johnson & Johnson's CAPLYTA® is now part of the broadest range of treatment options for adults with schizophrenia, including both oral and long-acting injectable therapies [1] - The company emphasizes its commitment to ongoing research and development to support the long-term use of CAPLYTA® in neuropsychiatric disorders [2] Industry Context - Schizophrenia affects an estimated 2.8 million adults in the U.S., with around 40% of individuals not receiving adequate treatment [2][6] - Relapses in schizophrenia can lead to significant functional decline and increased caregiver burden, highlighting the importance of effective relapse prevention strategies [2][6] - The Phase 3 trial results indicate that CAPLYTA® could play a critical role in managing schizophrenia and preventing relapses, which is essential for patient stability and reducing hospitalization rates [2][7]