CAPLYTA (lumateperone) Open-Label Safety Switching Study in Patients with Schizophrenia Published in the Journal, Schizophrenia Research

Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to previous or another approved antipsychotic.

In patients with stable symptoms of schizophrenia, CAPLYTA was well-tolerated with low rates of metabolic and extrapyramidal symptoms (EPS) adverse events; schizophrenia symptoms remained stable and did not worsen from baseline.

NEW YORK, Jan. 21, 2021 (GLOBE NEWSWIRE) -- In^tra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the publication of results from the CAPLYTA clinical trial (ITI-007-303) in adult patients with schizophrenia. The article, "Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia" (Correll et al. 2021), was recently published online in Schizophrenia Research and is available here.

The objective of this 6-week open-label study was to evaluate the safety and tolerability of CAPLYTA with stable schizophrenia patients switched from another antipsychotic treatment. The most common drug-related treatment emergent adverse events during CAPLYTA treatment were somnolence (6.6%), headache (5.3%) and dry mouth (5.3%). Reports of EPS were low (1%).

After 6 weeks of CAPLYTA treatment, it was observed that the mean total cholesterol, low-density lipoprotein (LDL) cholesterol, body weight and prolactin levels decreased from baseline. At the conclusion of the treatment period with CAPLYTA, patients were switched back to their previous or another approved antipsychotic. In a prespecified secondary safety analysis, conducted 2 weeks after discontinuing CAPLYTA, it was observed that the mean total cholesterol, LDL cholesterol, body weight and prolactin levels increased. In this study, patients’ schizophrenia symptoms remained stable and did not worsen from baseline.

These data further support the safety, tolerability and effectiveness of CAPLYTA in patients with schizophrenia and provide important information to clinicians.

“Weight gain and metabolic side effects or motor disturbances are leading reasons for healthcare providers to switch antipsychotics. Scientific results from studies that resemble a real world clinical setting and published in the medical literature provide important information for clinicians to make informed treatment decisions,” said Dr. Christoph Correll, Professor of Psychiatry and Molecular Medicine at the Zucker School of Medicine at Hofstra/Northwell, New York. “CAPLYTA is a valuable addition to the armamentarium to help treat this challenging mental illness.”