Johnson & Johnson submits FDA application for Caplyta to prevent schizophrenia relapse
Ella Day | July 18, 2025 | News story | Medical Communications, Research and Development | CAPLYTA, Johnson & Johnson, Neurology, US Food and Drug Administration, neuroscience, new drug application, schizophrenia
Johnson & Johnson has submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Caplyta (lumateperone) to prevent relapse in adults with schizophrenia. It is currently approved by the FDA to treat the brain disorder.
The submission is supported by data from a phase 3 study demonstrating that patients taking Caplyta experienced a 63% reduced risk of relapse compared to the placebo group. Time to relapse was significantly longer in the Caplyta group, and the medication also delayed discontinuation for any reason. No new safety concerns identified and the most commonly reported side effect was a headache.
“For people living with schizophrenia, relapses can be devastating,” said Christoph Correll, clinical professor of psychiatry at Hofstra/Northwell, New York, US. “Caplyta substantially lowers the chance of relapse for patients compared to placebo.”
Schizophrenia affects nearly 2.8 million adults in the US, with high rates of relapse and hospitalisation. If left untreated, it can cause episodes of psychosis, hallucinations or other disruptive behaviours. As well as schizophrenia, Caplyta is approved to treat bipolar depression and is currently under review for major depressive disorder.
“This is a critical step in helping to break the cycle of hospitalisation and support long-term stability,” said Bill Martin, global head of neuroscience, Johnson & Johnson.
Ella Day
18/7/25
This article featured in: August 2025 – The Pharmafile Brief
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