Thursday, December 26, 2019

FDA Approves Caplyta to Treat Schizophrenia in Adults

The Food and Drug Administration (FDA) this week approved Caplyta (lumateperone), an oral atypical antipsychotic medication to treat schizophrenia in adults.

“Schizophrenia is a complex disease that severely impacts patients and their families,” Jeffrey A. Lieberman, M.D., the Lawrence C. Kolb Professor and Chairman of Psychiatry at Columbia University, said in a statement. “Effective treatment provided in a timely fashion can be game-changing for people living with schizophrenia. The efficacy and safety profile of Caplyta … offers health care providers an important new option for treating people living with schizophrenia.”

The approval of Caplyta was supported by two four-week, placebo-controlled trials involving a total of 785 adults with schizophrenia. In both trials, patients receiving 42 mg lumateperone achieved a statistically significant reduction in the Positive and Negative Syndrome Scale (PANSS) score at the end of 28 days compared with placebo. In the first trial, the PANSS score decreased 13.2 points in the treatment group compared with 7.4 points in the placebo group. In the second trial, the PANSS score decreased 14.5 points in the treatment group compared with 10.3 points in the placebo group. The most common adverse reactions were sleepiness/sedation and dry mouth.

The labeling for Caplyta includes a boxed warning noting that older patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death. Caplyta is not approved for the treatment of patients with dementia-related psychosis.

According to Intra-Cellular Therapies, the company will launch Caplyta in the next few months.

For related information, see the American Journal of Psychiatry article “Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.”

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