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Johnson & Johnson (NYSE:JNJ) has submitted a supplemental New Drug Application (sNDA) to the FDA for CAPLYTA® (lumateperone) based on impressive Phase 3 trial results in schizophrenia relapse prevention. The study demonstrated a 63% reduction in relapse risk compared to placebo, with significantly longer time to relapse during the 26-week double-blind treatment phase (p=0.0002).
The trial's safety profile remained consistent with existing clinical data, with headache being the most common adverse event. CAPLYTA® is already FDA-approved for schizophrenia treatment and is the first approved therapy for both bipolar I and II depression. The drug's mechanism involves high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy at therapeutic doses.