12 Feb FDA Approves Caplyta (lumateperone) for Schizophrenia

MedicalResearch.com Interview with:

Dr. Satlin

Andrew Satlin, M.D.
Chief Medical Officer
Intra-Cellular Therapies

MedicalResearch.com: What is the background for this announcement? How does CAPLYTA (lumateperone) differ from other medications for schizophrenia?

Response: Schizophrenia is a serious mental illness and complex disease that presents itself differently in various patients. Antipsychotics are associated with side effects such as weight gain and metabolic disturbances and movement disorders. Many patients often discontinue treatment as a result of these side effects. The U.S. Food and Drug Administration (FDA) has approved CAPLTA (lumateperone) for the treatment of schizophrenia in adults. We are excited to provide a new option for treating patients living with schizophrenia with an established efficacy and a favorable weight, metabolic and motor side effect profile.

MedicalResearch.com: What are the main findings of recent studies?

Response: 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.

MedicalResearch.com: What should readers take away from your report? When might it be available for prescriptions use in the US?

Response: Schizophrenia is a debilitating disease with a diverse clinical presentation. 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. The approval of CAPLYTA is supported by two placebo-controlled trials, where CAPLYTA showed significant benefit over placebo on the accepted measure of clinical efficacy for schizophrenia studies, the Positive and Negative Syndrome Scale (PANSS) total score. The efficacy and safety profile of CAPLYTA as described in the prescribing information approved by the FDA offers healthcare providers an important new option for treating people living with schizophrenia. We expect CAPLYTA to be available to US consumers in late Quarter 1.

MedicalResearch.com: Is there anything else you would like to add? Any disclosures?

Response: We are excited to provide healthcare providers with a new, safe and effective treatment option to help the millions of adult patients with schizophrenia.

Andrew Satlin, M.D., is the Chief Medical Officer at Intra-Cellular Therapies Inc.

Important Safety Information

Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

• Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
• Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include: hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and close monitoring.
• Tardive Dyskinesia, a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. Discontinue CAPLYTA if clinically appropriate.
• Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
• Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
• Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease.
• Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
• Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
• Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
• Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
• Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration. 

Drug Interactions: Avoid concomitant use with CYP3A4 inducers and moderate or strong CYP3A4 inhibitors.

Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Avoid use in patients with moderate or severe hepatic impairment. 

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

Click here for full Prescribing Information, including Boxed Warning. 

CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.

Copyright © 2019, Intra-Cellular Therapies, Inc. All rights reserved.

FDA has approved CAPLYTA (lumateperone) for the treatment of schizophrenia in adults

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Last Updated on February 12, 2020 by Marie Benz MD FAAD