The FDA has approved Caplyta for the treatment of schizophrenia in adults, according to a press release from the agent’s manufacturer.
“We believe Caplyta provides health care 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 the release. “This approval represents the culmination of years of scientific research. We are especially grateful to the patients, their caregivers and the health care professionals who have contributed to the development of Caplyta.”
Caplyta (lumateperone, Intra-Cellular Therapies Inc.) demonstrated efficacy in two placebo-controlled trials that showed a statistically significant separation from placebo on the Positive and Negative Syndrome Scale total score. In these trials, the most common adverse reactions for the recommended dose (42 mg) of Caplyta vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).
Pooled data from short-term studies revealed similar outcomes between Caplyta and placebo for fasting glucose, mean changes from baseline in weight gain, triglycerides and total cholesterol. Further, the incidence of extrapyramidal symptoms was 6.7% for Caplyta vs. 6.3% for placebo.
Although the mechanism of action for Caplyta is currently unknown, its efficacy may 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 the release. Intra-Cellular Therapies expects to initiate the commercial launch of Caplyta in the first quarter of 2020.
The drug is being further developed to treat disorders beyond schizophrenia, including bipolar depression, behavioral disturbances in patients with dementia, depression and other neurological and neuropsychiatric disorders.
“Schizophrenia is a complex disease that severely impacts patients and their families,” Jeffrey A. Lieberman, MD, Lawrence C. Kolb Professor and Chairman of psychiatry at Columbia University’s College of Physicians and Surgeons, said in the 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 health care providers an important new option for treating people living with schizophrenia.”
Intra-Cellular Therapies. FDA approves Intra-Cellular Therapies’ novel antipsychotic, Caplyta (lumateperone) for the treatment of schizophrenia in adults. https://ir.intracellulartherapies.com/news-releases/news-release-details/fda-approves-intra-cellular-therapies-novel-antipsychotic. Accessed Dec. 23, 2019.