Adjunctive Sildenafil Improved Negative Symptoms

The FDA has approved a new, once-daily atypical antipsychotic lurasidone (Latuda) for the treatment of schizophrenia in adults.1 According to the manufacturer, the FDA reviewed data from >40 clinical trials involving >2500 patients. The approval was based on results of four 6-week placebo-controlled trials in which lurasidone produced significantly greater improvement than placebo on the Positive and Negative Syndrome Scale and the Brief Psychiatric Rating Scale.2 None of the placebo-controlled trials had a duration of >6 weeks, and the effectiveness of lurasidone for longer-term use has not been established. Common adverse effects include akathisia, nausea, tremor, parkinsonism, and agitation. In short-term studies, lurasidone produced a mean weight gain of <2 lbs, and in longer-term open-label extension studies, patients lost an average of 1.5 lbs over 1 year. The recommended starting dosage is 40 mg once daily, and the maximum dosage is 80 mg/day. Lurasidone should be taken with food. As with all other atypical antipsychotics, the lurasidone label will carry a Boxed Warning on increased risk of death in elderly patients treated for dementia-related psychosis (an unapproved indication). Lurasidone is expected to be available in U.S. pharmacies in early 2011. 1FDA News Release: FDA Approves Latuda to treat schizophrenia in adults. Available at www.fda.gov. 2FDA approves once-daily Latuda (lurasidone HCl) for the treatment of patients with schizophrenia [press release]. Marlborough, Mass: Sunovion Pharmaceuticals Inc; October 28, 2010.