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185 The Safety and Tolerability of Lumateperone 42 mg for the Treatment of Schizophrenia: A Pooled Analysis of 3 Randomized Placebo-Controlled Trials

Published online by Cambridge University Press:  24 April 2020

John M Kane ,
Kimberly E Vanover ,
Suresh Durgam ,
Robert Davis ,
Andrew Satlin ,
William Rowe ,
Sharon Mates  and
Carol Tamminga
John M Kane
Affiliation:
Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, USA Division of Psychiatry Research, The Zucker Hillside Hospital, Northwell Health, New York, NY, USA Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Northwell/Hofstra, Hempstead, NY, USA
Kimberly E Vanover
Affiliation:
Intra-Cellular Therapies, Inc., New York, USA
Suresh Durgam
Affiliation:
Intra-Cellular Therapies, Inc., New York, USA
Robert Davis
Affiliation:
Intra-Cellular Therapies, Inc., New York, USA
Andrew Satlin
Affiliation:
Intra-Cellular Therapies, Inc., New York, USA
William Rowe
Affiliation:
Intra-Cellular Therapies, Inc., New York, USA
Sharon Mates
Affiliation:
Intra-Cellular Therapies, Inc., New York, USA
Carol Tamminga
Affiliation:
University of Texas Southwestern Medical School, Dallas, Texas, USA
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Abstract:

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Introduction:

Lumateperone (ITI-007) is in late-phase clinical development for schizophrenia. Lumateperone has a unique mechanism of action that modulates serotonin, dopamine, and glutamate neurotransmission. This pooled analysis of lumateperone in 3 randomized, double-blind, placebo-controlled studies was conducted to evaluate the safety and tolerability of lumateperone 42mg (ITI-007 60mg).

Methods:

Data were pooled from the 3 controlled late-phase studies of lumateperone 42mg in patients with acute exacerbation of schizophrenia. Safety assessments of all patients who received at least one dose of any treatment included treatment-emergent adverse events (TEAEs), changes in laboratory parameters, extrapyramidal symptoms (EPS), and vital signs.

Results:

The safety population comprised 1,073 patients (placebo [n=412], lumateperone 42mg [n=406], risperidone [n=255]). TEAEs that occurred in the lumateperone 42mg group at a rate of ≥5% and twice placebo were somnolence/sedation (24.1% vs 10.0%) and dry mouth (5.9% vs 2.2%). Rates of discontinuation due to TEAEs with lumateperone 42mg (0.5%) were similar to placebo (0.5%) and lower than risperidone (4.7%). Mean change in weight and rates of EPS-related TEAEs were less for lumateperone 42mg and placebo patients than risperidone patients. Mean change from baseline in metabolic parameters were similar or smaller for lumateperone 42mg vs placebo. Mean changes were notably higher in risperidone patients vs lumateperone 42mg and placebo for glucose, cholesterol, triglycerides, and prolactin.

Conclusion:

In this pooled analysis, lumateperone 42mg showed good tolerability with potential benefits over risperidone for metabolic, prolactin, and EPS risks. The only TEAE that occurred in >10% of lumateperone patients was somnolence/sedation, which was impacted by morning administration; in subsequent studies that administered lumateperone in the evening, somnolence/sedation rates were markedly reduced. These results suggest that lumateperone 42mg may be a promising new treatment for schizophrenia.

Funding Acknowledgements:

Supported by funding from Intra-Cellular Therapies, Inc.

Type
Abstracts
Information
CNS Spectrums , Volume 25 , Issue 2 , April 2020 , pp. 316 - 317
Copyright
© Cambridge University Press 2020