Abstract
Oral lumateperone (Caplyta®) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults in the USA. As a mechanistically novel agent that selectively and simultaneously modulates serotonin, dopamine, and glutamate neurotransmission, it offers a new option for the management of this severe and debilitating mental disorder. Across three phase 2 or 3 studies in patients with an acute exacerbation of schizophrenia, double-blind treatment with lumateperone 42 mg/day for 4–6 weeks significantly improved psychotic symptoms and global disease severity compared with placebo. Additionally, open-label treatment with lumateperone for up to 1 year was associated with continuous improvements in psychotic symptoms in patients with stable schizophrenia switched from standard-of-care antipsychotics. Lumateperone therapy is generally well tolerated, with a placebo-like and comparatively favourable safety profile with respect to motor, metabolic and cardiovascular issues.
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Acknowledgements
The manuscript was reviewed by: J. R. Brašić, Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA; A. C. Yang,Institute of Brain Science and Digital Medicine Center, National Yang-Ming University, Taipei, Taiwan. During the peer review process, Intra-Cellular Therapies Inc., the marketing-authorization holder of lumateperone, was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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J.E. Frampton is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
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Enhanced material for this Adis Drug Q&A can be found at https://doi.org/10.6084/m9.figshare.12965078.
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Frampton, J.E. Lumateperone in schizophrenia: a profile of its use. Drugs Ther Perspect 36, 477–484 (2020). https://doi.org/10.1007/s40267-020-00780-4
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DOI: https://doi.org/10.1007/s40267-020-00780-4