FDA representatives have approved lumateperone intracellular therapy (Caplyta) for the treatment of adult schizophrenia, according to the company. It is expected that the drug will be launched in 2020.

Lumateperone has been approved as an oral, once daily medication approved for the treatment of adult schizophrenia (42 mg / day). The mechanism of action of lumateperone in the treatment of schizophrenia is unknown. However, the effectiveness of the drug can be mediated through a combination of antagonistic activity against central serotonin 5-HT2A receptors and postsynaptic antagonistic activity against central dopamine D2 receptors, according to intracellular therapy.

Schizophrenia affects approximately 2.4 million adults in the United States. The clinical picture 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, a gradual deterioration in social functioning and cognitive abilities. Patients with schizophrenia often stop treatment as a result of side effects such as weight gain and motor disorders.

“Schizophrenia is a complex disease that has a serious impact on patients and their families,” said Jeffrey A. Lieberman, MD, Professor Lawrence K. Colba and chairman of psychiatry at Columbia University College of Physicians and Surgeons and director of the New State Psychiatric Institute York. in the prepared statement. “Effective treatment provided on time can change the rules of the game for people living with schizophrenia.” An FDA-approved Caplyta Safety and Efficiency Profile offers healthcare providers an important new treatment option for people living with schizophrenia. ”

42 mg of Lumetherone was demonstrated in 2 placebo-controlled trials, showing a statistically significant separation from placebo at the primary endpoint, on the General Positive and Negative Syndrome Scale (PANSS). The most common adverse reactions (≥5% and a doubled placebo frequency) for the recommended dose of lumateperone compared with placebo were drowsiness / sedation (24% versus 10%) and dry mouth (6% versus 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.

Lumateperone Intracellular Therapy comes with a boxed warning. The warning reveals that older patients with dementia-related psychosis receiving antipsychotic drugs are at an increased risk of death, and that lumateperone is not approved for the treatment of patients with dementia-related psychosis.