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Antipsychotic Iloperidone Results Show Favorable Akathisia Profile

emor, slurred speech, restlessness and involuntary muscle movement) during the course of the study. In contrast, 5% of low-dose and 11% of high-dose iloperidone patients received anticholinergic medication.

"Iloperidone may be less likely to worsen akathisia because of its novel mechanism of action," said Paolo Baroldi, M.D., Ph.D., Chief Medical Officer, Vanda Pharmaceuticals Inc. "Akathisia is believed to be due to D2 activation, which is not present with iloperidone."

About the Study

In this Phase III randomized, double-blind, placebo- and risperidone- controlled, international multi-center six-week study conducted by Novartis, patients were randomized to one of four treatment groups: iloperidone low- dose (12.16 mg/d, n=244), iloperidone high-dose (20.24 mg/d, n=145), risperidone (6.8 mg/d, n=157) or placebo (n=160).

Patients enrolled in the study were 62% male (n=435) and 38% female (n=271), approximately 39 years of age, and had a diagnosis of schizophrenia or schizoaffective disorder with a Positive and Negative Syndrome Scale (PANSS) score greater than or equal to 60 at baseline.

Anticholinergic drugs for the treatment of EPS were permitted during the two-day placebo run-in period. EPS must have improved and anticholinergics discontinued for more than 24 hours prior to baseline measurement.

Changes in akathisia were measured weekly by the BAS and the Extrapyramidal Symptom Rating Scale (ESRS) from baseline to the six-week end point for patients in all treatment groups. Categorical analysis was conducted to determine the percentage of patients with akathisia that worsened, remained unchanged, or improved, from baseline, during the treatment period. Use of anticholinergics (benztropine or biperiden) was allowed during the double-blind phase in all four groups for treatment-emergent EPS, after assessment was completed by the EPS rating scales.

About Iloperidone

Iloperidone is an atypical antipsychotic, wit
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