Intra-Cellular Therapies Announces Availability of Lumateperone for Adult Patients with Schizophrenia

Intra-Cellular Therapies, Inc (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Caplyta (lumateperone) is now available to pharmacies in the United States. Caplyta is an oral, once daily medicine approved for the treatment of schizophrenia in adults.

“At Intra-Cellular Therapies, we understand the lifelong debilitating struggle people with schizophrenia experience. The need for new treatment options for this community has driven our efforts to bring Caplyta to market,” said Mark Neumann, Chief Commercial Officer of Intra-Cellular Therapies. “We have an experienced commercial team and have developed a comprehensive strategy with a multi-channel promotional plan to support the launch of Caplyta in light of the ongoing COVID-19 pandemic. In addition, affordability support programs are available to eligible Caplyta patients.”

The efficacy of Caplyta 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over 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 recognize this is an extraordinary and challenging time with COVID-19; we are monitoring developments closely and we will adapt our approach as appropriate. To complement our current launch plan, we have developed remote capabilities for detailing, sampling and peer to peer interactions designed to ensure physicians are properly educated on Caplyta. We will also rely more heavily on digital promotion to augment the remote interactions of our sales colleagues.

We have substantial product supply in the United States. with long expiry dating to support expected demand. Each 30-capsule pack of Caplyta covers once daily dosing for one month. Sample packs of 10 capsules are available for healthcare professionals. More information about Caplyta is available at 888-252-ITCI or at CAPLYTA.com.

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 are reasonably certain Caplyta therapy does not affect them adversely.
• 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%).

Please click here to see full Prescribing Information including Boxed Warning.

About Caplyta (lumateperone)

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.

About Intra-Cellular Therapies

Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

Source: Intra-Cellular Therapies