Drug Receives FDA Approval for Schizophrenia Treatment

Officials with the FDA have approved Intra-Cellular Therapies’ lumateperone (Caplyta) for the treatment of schizophrenia in adults, according to the company. The drug is expected to be launched in 2020.

Lumateperone was approved as an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day). The mechanism of action of lumateperone in the treatment of schizophrenia is unknown. However, the drug's 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, according to Intra-Cellular Therapies.

Schizophrenia impacts approximately 2.4 million adults in the United States. The clinical presentation of schizophrenia is diverse. Acute episodes are characterized by psychotic symptoms, including hallucinations and delusions, often requiring hospitalization. The disease is chronic and lifelong, often accompanied by depression, and gradual deterioration of social functioning, and cognitive ability. Patients with schizophrenia often discontinue treatment as a result of adverse effects such as weight gain, and movement disorders.

“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, in a prepared statement. “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 health care providers an important new option for treating people living with schizophrenia.”

The efficacy of lumateperone in 42 mg was demonstrated in 2 placebo-controlled trials, showing a statistically significant separation from 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 lumateperone 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 lumateperone and placebo. The incidence of extrapyramidal symptoms was 6.7% for lumateperone and 6.3% for placebo.

Intra-Cellular Therapies’ lumateperone comes with a Boxed Warning. The warning discloses that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, and that lumateperone is not approved for the treatment of patients with dementia-related psychosis.

REFERENCE

FDA Approves Intra-Cellular Therapies’ Novel Antipsychotic, CAPLYTA® (lumateperone) for the Treatment of Schizophrenia in Adults [news release]. New York, NY; December 23, 2019: Intra-Cellular Therapies. https://ir.intracellulartherapies.com/news-releases/news-release-details/fda-approves-intra-cellular-therapies-novel-antipsychotic Accessed December 24, 2019.