The Food and Drug Administration (FDA) has approved Caplyta (lumateperone; Intra-Cellular Therapies), an atypical antipsychotic, for the treatment of schizophrenia in adult patients.

The approval was based on results from 2 double-blind, placebo-controlled trials (Study 1 [N=335] and Study 2 [N=450]) that evaluated the efficacy of Caplyta in patients with schizophrenia for 28 days. Findings from Study 1 and Study 2 showed that Caplyta 42mg once daily demonstrated a statistically significant reduction from baseline to Day 28 in the Positive and Negative Syndrome Scale (PANSS) total score with a placebo-subtracted difference of -5.8 (95% CI: -10.5, -1.1) and -4.2 (95% CI: -7.8, -0.6), respectively.

With regard to safety, Caplyta carries a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis. The most common adverse reactions were somnolence/sedation and dry mouth. Pooled data from short-term trials showed similar changes in weight gain, fasting glucose, triglycerides and total cholesterol in the Caplyta and placebo arms; the incidence of extrapyramidal symptoms was 6.7% with Caplyta and 6.3% with placebo.

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“Schizophrenia is a complex disease that severely impacts patients and their families,” said Jeffrey A. Lieberman, MD, Lawrence C. Kolb Professor and Chairman of Psychiatry, Columbia University, College of Physicians and Surgeons and Director, New York State Psychiatric Institute. “Effective treatment provided in a timely fashion can be game-changing for people living with schizophrenia. The efficacy and safety profile of Caplyta approved by the FDA, offers healthcare providers an important new option for treating people living with schizophrenia.”

The exact mechanism of action of Caplyta in the treatment of schizophrenia is unknown, but it is believed to be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

The product will be supplied as 42mg capsules in 30-count boxes.

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