Lumateperone in schizophrenia: a profile of its use
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ADIS DRUG Q&A
Lumateperone in schizophrenia: a profile of its use James E. Frampton1 Published online: 6 October 2020 © Springer Nature Switzerland AG 2020
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.
Adis evaluation of oral lumateperone in the treatment of schizophrenia in adults Selectively and simultaneously modulates serotonin, dopamine, and glutamate neurotransmission Administered once daily with food; no dose titration required Improves psychotic symptoms and global disease severity in patients with an acute exacerbation of schizophrenia May further improve psychotic symptoms in patients with stable schizophrenia switched from other antipsychotics Generally well tolerated, with a short-term safety profile similar to that of placebo
Enhanced material for this Adis Drug Q&A can be found at https ://doi.org/10.6084/m9.figshare.12965078. * James E. Frampton [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
What is the rationale for developing lumateperone in schizophrenia? Schizophrenia is a chronic, severe, and debilitating mental disorder characterized by a range of ‘positive’ (e.g. hallucinations and delusions) and ‘negative’ (e.g. flat affect and social withdrawal) symptoms, and cognitive impairment (e.g. learning and attention disorders) [1]. It affects ≈ 1% of the general population worldwide, often with substantial social and economic implications [1, 2]. Antipsychotic agents are the cornerstone of the pharmacological management of schizophrenia, with newer, second-generation (atypical) agents usually being preferred over older, first-generation (conventional) agents, mainly on account of their lower propensity to cause extrapyramidal symptoms (EPS) [3, 4]. However, atypical antipsychotics are a heterogeneous drug class wherein individual members are associated with varying degrees of risk for a number of potentially treatment-limiting adverse events that may be related to their differing pharmacological profiles in terms of binding to dopaminergic, serotonergic, noradrenergic, histaminic, and muscarinic r
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