Johnson & Johnson — Caplyta (lumateperone) $JNJ
for schizophrenia
FDA approved a supplemental New Drug Application for Caplyta (lumateperone) based on long-term data supporting reduced relapse risk in schizophrenia.
for schizophrenia
FDA approved a supplemental New Drug Application for Caplyta (lumateperone) based on long-term data supporting reduced relapse risk in schizophrenia.
Schizophrenia is a mental disorder marked by hallucinations, delusions, disorganized thinking, and flat or inappropriate affect — symptoms that usually emerge in young adulthood and can disrupt a person's relationships, work, and daily life. Caplyta (lumateperone) is a once-daily oral medicine that calms overactive signaling in the brain. By steadying that brain activity, Caplyta may help ease symptoms and lower the chance they return, though how well it works varies from person to person.
The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
Source: ClinicalTrials.gov