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FDA Approves Lurasidone for the Treatment of Schizophrenia

October 28, 2010
FDA, Food and Drug Administraion, Psychiatry, FDA Report, Report

On October 28th, the United States Food and Drug Administration approved lurasidone HCl (Latuda, Sunovion Pharmaceuticals) for the treatment of schizophrenia. Patients should be initiated on 40 mg/day which be titrated to a maximum of 80 mg/day. Either dosage should be taken with food.

Approval was based on four, 6-week, placebo-controlled studies in adults 18–72 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for schizophrenia. The Positive and Negative Syndrome Scale (PANSS) was used to evaluate the efficacy of lurasidone in schizophrenia. Positive symptoms and current illness state were assessed using The Brief Psychiatric Rating Scale derived (BPRSd) and The Clinical Global Impression severity scale (CGI-S), respectively.

At endpoint of two trials, (N=145; N=180), lurasidone 40 mg/day and 120 mg/day were superior to placebo on the BPRSd and the CGI-S. At the endpoint of a trial of 473 patients, lurasidone 40 mg/day and 80 mg/day were superior to placebo on the PANSS and the CGI-S. Finally, the last trial, with 489 patients, found that lurasidone 80 mg/day was superior to placebo on the PANSS and the CGI-S.

The most commonly observed adverse events included somnolence, akathisa, nausea, parkinsonism, and agitation. These adverse events were seen in >5% of the patients studied.

For additional safety and prescribing information, please visit http://www.latuda.com. —Christopher Naccari

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From → FDA Report

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