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FDA Approves Novel Antipsychotic From Intra-Cellular Therapies

January 02, 2020

The US Food and Drug Administration (FDA) has approved lumateperone (Caplyta), a novel antipsychotic from Intra-Cellular Therapies, Inc., for the treatment of schizophrenia in adults.

“We believe Caplyta provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies. The company expects to begin the commercial launch of the drug late in the first quarter of 2020.

Lumateperone is an oral medicine dosed at 42 mg once daily. In 2 placebo-controlled trials, it showed a statistically significant separation from placebo on the Positive and Negative Syndrome Scale (PANSS) total score. The most common adverse reactions for the recommended dose of lumateperone vs placebo were somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%).

In pooled data from short-term studies, mean changes in weight gain, fasting glucose, triglycerides, and total cholesterol were similar for lumateperone and placebo. The incidence of extrapyramidal symptoms for lumateperone was 6.7%, compared with 6.3% for placebo.

Lumateperone’s mechanism of action in the treatment of schizophrenia is unknown. According to a statement from Intra-Cellular, its efficacy "could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors."

The drug will carry a Boxed Warning indicating it is not approved for the treatment of patients with dementia-related psychosis, who are at an increased risk of death when treated with antipsychotics. See the full Prescribing Information here.

Lumateperone is also being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression, and other neuropsychiatric and neurological disorders.

—Terri Airov


FDA approves Intra-Cellular Therapies’ novel antipsychotic, Caplyta (lumateperone) for the treatment of schizophrenia in adults [press release]. New York, NY: Intra-Cellular Therapies; Dec. 23, 2019.

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