Benzinga | Jun 7, 2021 08:09AM EDT

Intra-Cellular Therapies Says Co's CAPLYTA Schizophrenia Safety And Tolerability Profile Published In The Journal 'International Clinical Psychopharmacology'

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 the article, "Safety and tolerability of lumateperone: a pooled analysis of late-phase placebo-and active-controlled clinical trials" (Kane et al. 2021), was recently published online in International Clinical Psychopharmacology.

This pooled analysis of 3 randomized, double-blind, placebo-controlled trials was conducted to evaluate the safety and tolerability of lumateperone 42 mg. The pooled population comprised of 1,073 patients with an acute exacerbation of schizophrenia randomized to placebo (n=412), lumateperone 42 mg (n=406), or risperidone 4 mg (n=255). Risperidone was included for assay sensitivity and not included for a comparison between CAPLYTA and risperidone.

In this pooled analysis, lumateperone 42 mg had a safety profile similar to placebo. Treatment-emergent adverse events (TEAEs) were predominantly mild and mean changes in weight and metabolic parameters as well as motor adverse events were similar to placebo. Rates of discontinuation due to treatment emergent adverse events (TEAEs) with lumateperone 42 mg (0.5%) were similar to placebo (0.5%) and lower than risperidone (4.7%). The only TEAEs that occurred at a rate of ? 5% and twice placebo for lumateperone were somnolence/sedation and dry mouth.

Mean change from baseline in metabolic parameters and prolactin were similar to or reduced in lumateperone 42 mg relative to placebo treated patients and were smaller than risperidone. Mean change in weight and rates of EPS-related TEAEs were similar for lumateperone 42 mg and placebo treated patients and less than for risperidone treated patients. This pooled analysis highlights the distinct safety and favorable tolerability profile of lumateperone 42 mg.

"CAPLYTA is an important addition in the treatment armamentarium for adult patients with schizophrenia. The achievement of efficacy while maintaining a favorable safety and tolerability profile in weight change, metabolic side effects and motor disturbances represents a significant advance as these adverse events are commonly associated with poor treatment adherence," said Dr. John Kane, Chair of Psychiatry and Professor of Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine, Hofstra/Northwell, New York.

CAPLYTA(r) (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.