Lurasidone, an atypical antipsychotic, has been approved for treating adults with schizophrenia, the Food and Drug Administration announced Oct. 28.
The approval of lurasidone was based on the results of four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, which found that those treated with lurasidone had a greater response to treatment with lurasidone than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug’s prescribing information.
Lurasidone, which comes in a tablet formulation, will be marketed by Sunovion Pharmaceuticals Inc. as Latuda. It will be available in February 2011, according to the company, which was previously called Sepracor Inc.
A recommended initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.
In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA’s statement announcing the approval. Like other atypical antipsychotics, the label of lurasidone has a boxed warning about the increased risk of death when these drugs are used off label to treat elderly patients with dementia-related psychosis. None of the atypical antipsychotics is approved for that indication.
In the FDA statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because "some patients do not respond well to certain types of drug therapy."