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Vanda Presents Phase III Iloperidone Efficacy Data
Date:12/12/2007

CATIE trial on antipsychotics," said Andrew J. Cutler, M.D., principal investigator of the Phase III study and Assistant Professor of Psychiatry at the University of Florida. "Iloperidone's combination of comparable efficacy and favorable tolerability profile is good news for physicians and patients as a potential new treatment option."

Iloperidone and ziprasidone showed similarly low effects on glucose, cholesterol, triglyceride and prolactin levels compared to placebo. Iloperidone also had a similar akathisia profile to placebo, whereas ziprasidone was associated with a significant worsening of akathisia versus placebo on the Barnes Akathisia Scale (BAS), with 26 percent of patients experiencing a worsening of akathisia. Iloperidone was also associated with a favorable profile on the Extrapyramidal Symptoms Rating Scale (ESRS) versus placebo.

"Akathisia is a debilitating sensation of restlessness that can be unrelenting and around the clock. The new research findings from the recent clinical trials of iloperidone suggest that iloperidone may have a very low akathisia profile, one of the features of this new medication that should be very good news for patients with schizophrenia and the physician community," said Dr. Peter Weiden, M.D., Director of the Psychosis Program of the Department of Psychiatry at the University of Illinois at Chicago and one of the leading experts on adverse events of antipsychotic medications.

A post-hoc, pooled analysis of three additional Phase III trials was also presented this week. Each trial was a randomized, double-blind, placebo- and active-controlled, parallel-group, six-week trial of patients with schizophrenia or schizoaffective disorder. The analysis evaluated change from baseline using the Brief Psychiatric Rating Scale (BPRS) for the 1,553 patients who remained on treatment for more than two weeks. Iloperidone demonstrated generally significant improvements over placebo in doses ranging from 4-8 mg/day
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SOURCE Vanda Pharmaceuticals Inc.
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