Intra-Cellular Therapies Announces Availability of CAPLYTA for Schizophrenia

Intra-Cellular Therapies announced CAPLYTA (lumateperone) is now available to pharmacies in the U.S. CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults.

"At Intra-Cellular Therapies, we understand the lifelong debilitating struggle people with schizophrenia experience.  The need for new treatment options for this community has driven our efforts to bring CAPLYTA to market," said Mark Neumann, Chief Commercial Officer of Intra-Cellular Therapies.  "We have an experienced commercial team and have developed a comprehensive strategy with a multi-channel promotional plan to support the launch of CAPLYTA in light of the ongoing COVID-19 pandemic.  In addition, affordability support programs are available to eligible CAPLYTA patients."

The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. The most common adverse reactions (≥5% and twice the rate of placebo) for the recommended dose of CAPLYTA vs. placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%). In pooled data from short term studies, mean changes from baseline in weight gain, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was 6.7% for CAPLYTA and 6.3% for placebo.

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