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

Lumateperone is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

In two placebo-controlled trials, treatment with lumateperone (42 mg once daily) showed a statistically significant separation from placebo on the Positive and Negative Syndrome Scale total score (primary endpoint). The most common adverse reactions with lumateperone were somnolence/sedation (24%) and dry mouth (6%).

Pooled data from short-term studies showed similar average changes from baseline in body weight, fasting glucose levels, triglyceride levels, and total cholesterol levels between lumateperone and placebo. The incidence of extrapyramidal symptoms was 6.7% with lumateperone and 6.3% with placebo.

Lumateperone includes a boxed warning noting that elderly patients with dementia-related psychosis who are being treated with antipsychotic drugs are at an increased risk for death and that lumateperone is not approved for the treatment of patients with dementia-related psychosis.

The drug is an oral, once-daily medicine approved for the treatment of schizophrenia in adults (42 mg/day). The mechanism of action is unknown, the release notes, but could be mediated "through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors."

It is also being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer disease, depression, and other neuropsychiatric and neurologic disorders but has not been demonstrated to be safe and effective for these conditions.

"We believe Caplyta provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia," Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, said in a news release announcing approval.

"Schizophrenia is a complex disease that severely impacts patients and their families," Jeffrey A. Lieberman, MD, professor and chairman, Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York City, said in the news release.

"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," said Lieberman.

The company expects to launch the drug in the first quarter of 2020.

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