Caplyta Receives Approval for Schizophrenia

December 23, 2019 – The U.S. FDA has approved Caplyta® (lumateperone), manufactured by Intra-Cellular Therapies, to treat schizophrenia in adults. Caplyta is an atypical antipsychotic with a unique mechanism of action that targets three different neurotransmitters in the brain – serotonin, dopamine, and glutamate – believed to play a role in several neuropsychiatric disorders.

Schizophrenia is a severe, chronic neuropsychiatric disorder that affects less than 1% of the United States population. In most cases, symptoms manifest anywhere from the late teens to early 30s, with men usually experiencing their first symptoms earlier in life than women. Schizophrenia symptoms are varied and can include hallucinations and thought disorders, decreased ability to speak or express emotion, inability to experience pleasure, and difficulty with focus, memory, and logical thinking.

In clinical trials, patients who received Caplyta had a statistically significant improvement in total scores on the Positive and Negative Syndrome Scale (PANSS) compared to placebo. PANSS is a standardized clinical interview commonly used to measure the severity of a patient’s schizophrenia symptoms.

Recommended dosing is one 42mg capsule taken once a day with food. A black box warning cautions that there is an increased risk of mortality in elderly patients with dementia-related psychosis who receive antipsychotic drugs such as Caplyta. Caplyta should not be used to treat dementia-related psychosis.

Intra-Cellular Therapies has launched Caplyta at a wholesale acquisition cost (WAC) of $1,320 per 30 capsules.