Magazine article Clinical Psychiatry News

Lurasidone Gets Nod Based on Short-Term Data

Magazine article Clinical Psychiatry News

Lurasidone Gets Nod Based on Short-Term Data

Article excerpt

Another atypical antipsychotic, lurasidone, has been approved for treating adults with schizophrenia. The approval was based on the results of four short-term studies, the Food and Drug Administration announced.

In the four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, those treated with lurasidone had a greater response to treatment 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, previously called Sepracor Inc.

An 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. In the 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."

In an interview, psychiatrist Rakesh Karmacharya said that although lurasidone is "not drastically different from a mechanistic or a scientific viewpoint" from other atypical antipsychotics, it is "certainly helpful" to have another drug available to treat schizophrenia, since some patients respond to one drug and not to another, and patients might experience side effects with one drug but not another. …

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