Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic

International Journal of Clinical Practice
Leslie Citrome

Abstract

To describe the efficacy and safety of lurasidone for the treatment of schizophrenia. The pivotal registration trials were accessed by querying the literature databases PubMed, EMBASE, ISI Web of Knowledge, as well as http://www.fda.gov and http://www.clinicaltrials.gov for the search term 'lurasidone'. Product labelling provided additional information. All available clinical reports of studies were identified. Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports, abstracts and posters. Additional safety outcomes subject to NNH analysis were obtained from product labelling. Lurasidone is a second-generation antipsychotic approved for the treatment of schizophrenia at a recommended starting dose of 40 mg/day administered once daily with food (≥350 calories). The maximum recommended dose is 80 mg/day. Regulatory approval was based primarily on a clinical trial programme that included four 6-week randomised clinical trials demonstrating efficacy vs. placebo in acute patients with schizophrenia. One additional Phase II clinical trial was considered a failed study because neither lurasido...Continue Reading

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Related Concepts

Metabolic Process, Cellular
PRL
Antipsychotic Effect
Phase 3 Clinical Trials
Assay OF Haloperidol
Schizophrenia
Clinical Trial, Phase II
Microdosing Trials, Human
Drug Labeling
Lurasidone

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