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.
More experience and longer term use should determine whether lurasidone is associated with less weight gain and sedation than some of the other atypicals, noted Dr. Karmacharya, the medical director of the schizophrenia and bipolar disorder research clinic, McLean Hospital, Belmont, Mass.
He referred to preclinical data indicating that lurasidone binds weakly to receptors implicated in antipsychotic-induced weight gain, sedation, and cognitive effects, which might lead to a more favorable side-effect profile with long-term use, when compared to some of the other atypicals.
The preclinical data found that lurasidone binds weakly to histamine H1 receptors, which have been implicated in weight gain and sedation, to the 5HT2C receptor, which has also been implicated in weight gain, and to muscarinic receptors, which might be involved in some of the cognitive effects associated with antipsychotics, said Dr. Karmacharya, also of Harvard University.
He added that in the short-term clinical studies, lurasidone was not associated with weight gain but said that more experience with the drug is needed.
Dr. Karmacharya had no conflicts relevant to the approval.