- Johnson & Johnson (JNJ, Financial) submits a supplemental New Drug Application (sNDA) to the FDA for CAPLYTA® (lumateperone) for schizophrenia relapse prevention.
- Phase 3 trial shows CAPLYTA reduces relapse risk by 63% compared to placebo.
- CAPLYTA's safety profile consistent with previous data; headache most common adverse event.
Johnson & Johnson (JNJ) has advanced its strategic position in treating schizophrenia by submitting a supplemental New Drug Application (sNDA) to the U.S. FDA for CAPLYTA® (lumateperone). This submission is based on impressive Phase 3 trial results demonstrating a significant 63% reduction in the risk of relapse for patients compared to a placebo, as well as a longer time to all-cause discontinuation. The data highlights CAPLYTA's potential efficacy in addressing a critical need for relapse prevention in schizophrenia treatment.
These findings further expand on CAPLYTA's current approvals for treating schizophrenia and bipolar I and II depression, reinforcing Johnson & Johnson's leadership in the neuropsychiatric field. The study's safety profile remained consistent with existing clinical data, identifying headaches as the most common adverse event, observed at a rate greater than or equal to 5% and twice the rate of placebo.
CAPLYTA stands out in the market due to its unique profile, featuring high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy, which mirrors placebo-like effects on weight and metabolic profiles in shorter studies. It offers the convenience of once-daily dosing without the need for titration, providing significant benefits for patient adherence to treatment.
Looking forward, CAPLYTA is also under FDA review for adjunctive treatment in major depressive disorder. If approved, it could extend its therapeutic impact to another prevalent mental health disorder, further broadening its addressable market.
