Intra-Cellular Therapies' Caplyta Approved for Schizophrenia

Intra-Cellular Therapies’ Caplyta (lumateperone) earned the FDA’s approval for treatment of schizophrenia in adults.

The agency required a boxed warning for the drug to note that elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death and the drug has not been approved for such patients.

Caplyta is currently being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, depression and other neuropsychiatric and neurological disorders.