FDA Approves Intra-Cellular Therapies’ Novel Treatment of Schizophrenia in Adults

Intra-Cellular Therapies, Inc. recently announced that CAPLYTA (lumateperone) has been approved by the US FDA for the treatment of schizophrenia in adults. The company expects to initiate the commercial launch of CAPLYTA in late Q1 2020.

The efficacy of CAPLYTA 42 mg was demonstrated in two 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 CAPLYTA 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 CAPLYTA and placebo. The incidence of extrapyramidal symptoms was 6.7% for CAPLYTA and 6.3% for placebo.

“We believe CAPLYTA provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “This approval represents the culmination of years of scientific research. We are especially grateful to the patients, their caregivers, and the healthcare professionals who have contributed to the development of CAPLYTA.”

Schizophrenia is a serious mental illness impacting 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 side 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. “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.”

CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day). The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. CAPLYTA is 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. CAPLYTA has not been demonstrated to be safe and effective in these other areas. CAPLYTA was approved for the treatment of schizophrenia in adults by the U.S. Food and Drug Administration in December 2019.

Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson’s and Alzheimer’s disease. The company’s first product, CAPLYTA, has received FDA approval for the treatment of schizophrenia in adults and is in development for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer’s disease, depression and other neuropsychiatric and neurological disorders. Intra-Cellular Therapies is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The lead molecule in the Company’s PDE1 portfolio, ITI-214, is in development for the treatment of symptoms associated with Parkinson’s disease and for the treatment of heart failure.