The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for lumateperone (CAPLYTA), adding long-term clinical data supporting its use in maintaining stability and reducing relapse risk in adults with schizophrenia.
Schizophrenia is a chronic psychiatric disorder affecting approximately 2.8 million adults in the United States and is associated with high relapse rates, functional impairment, and increased risk of hospitalization.
The label update is supported by a Phase 3 randomized, double-blind, placebo-controlled withdrawal trial evaluating lumateperone 42 mg once daily. After an 18-week open-label stabilization phase, patients were randomized to continue lumateperone or switch to placebo for up to 26 weeks. Lumateperone significantly prolonged time to relapse compared with placebo (p=0.0002) and reduced the risk of relapse by 63% (hazard ratio, 0.37). At 6 months, 84% of patients receiving lumateperone remained relapse-free.
Lumateperone also significantly delayed time to all-cause treatment discontinuation, including discontinuation due to relapse. The safety profile observed in the study was consistent with prior clinical data, and no new safety concerns were identified. The most common treatment-related adverse event was headache, occurring in at least 5% of patients and at approximately twice the rate observed with placebo.
Long-term findings from a 12-month open-label extension study showed a mean weight change of –2.05 kg, with stable or improved metabolic parameters and no clinically relevant increases in prolactin or cardiometabolic measures.
Lumateperone is an atypical antipsychotic. While its exact mechanism of action is not fully understood, its clinical effects are thought to involve serotonin 5-HT2A receptor antagonism and modulation of dopamine D2 receptors. In prior short-term studies, lumateperone demonstrated a safety profile similar to placebo for weight change, metabolic parameters, and extrapyramidal symptoms.
CAPLYTA is currently approved in adults for the treatment of schizophrenia, as well as for depressive episodes associated with bipolar I or II disorder and as adjunctive therapy for major depressive disorder. This label update adds long-term data supporting its role in maintaining disease stability.
Source: Johnson & Johnson