FDA approves supplemental application for CAPLYTA (lumateperone) to include Phase 3 data showing reduced relapse risk in adults with schizophrenia.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for CAPLYTA to include data supporting relapse prevention in adults with schizophrenia. The decision is based on long-term Phase 3 evidence demonstrating sustained efficacy and a consistent safety profile, supporting CAPLYTA’s use as a maintenance treatment option.
The approval is supported by a Phase 3 randomized, double-blind, placebo-controlled withdrawal study in stabilized patients, in which lumateperone 42 mg once daily significantly extended time to relapse versus placebo (p=0.0002). Treatment was associated with a 63% reduction in relapse risk (hazard ratio 0.37 [95% CI 0.22–0.65]), with 84% of patients remaining relapse-free over six months, and also delayed time to all-cause treatment discontinuation. The safety profile remained consistent with prior studies, with no new safety signals identified and headache reported as the most common adverse event.
Clinical data from short-term studies showed limited effects on weight, metabolic parameters, and extrapyramidal symptoms. In a 12-month open-label extension, patients experienced a mean weight reduction of 2.05 kg, alongside stable or improved metabolic measures. No clinically meaningful increases in prolactin or cardiometabolic markers were observed in the Phase 3 relapse-prevention trial.
Christoph U. Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York stated that relapse remains a major challenge in schizophrenia care and noted that the delay in relapse and high relapse-free rate provide clinicians with an additional option to support long-term stability.
Celine Goldberger, MD, PhD, Vice President, Global Medical Affairs, Neuroscience, Innovative Medicine, Johnson & Johnson said the updated label reflects a focus on advancing evidence-based therapies that address both symptom control and sustained disease stability.
Schizophrenia affects approximately 2.8 million adults in the United States and remains significantly undertreated, with an estimated 40% of patients not receiving adequate care. Patients experience an average of about nine relapse episodes over six years, contributing to functional decline, repeated hospitalizations, and an economic burden estimated at $366.8 billion in 2024.
Lumateperone is an atypical antipsychotic with activity at serotonin 5-HT₂A and dopamine D₂ receptors and is approved for schizophrenia, depressive episodes associated with bipolar I or II disorder, and as adjunctive therapy for major depressive disorder. The updated label supports its use in reducing relapse risk in adults with schizophrenia.
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About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.