VANDA REPORTS POSITIVE RESULTS FROM SCHIZOPHRENIA STUDY

Vanda Pharmaceuticals has announced positive top-line results from the company's Phase III clinical trial evaluating iloperidone, an atypical antipsychotic, in patients with schizophrenia. Iloperidone demonstrated statistically significant improvement compared with placebo on the Positive and Negative Symptom Scale (PANSS), the trial's primary endpoint. Additionally, iloperidone achieved significant efficacy on the positive and negative symptom subscales of PANSS. The safety profile was consistent with what has been observed in previous iloperidone trials.

Vanda also evaluated iloperidone's efficacy and safety in patients with specific genetic profiles using its expertise in pharmacogenetics as part of its commitment to give physicians and patients information to help personalize their antipsychotic therapy. Vanda had previously identified a polymorphism in a gene, occurring in approximately 70 percent of patients, hypothesized to be associated with the pathogenesis of schizophrenia which appeared to correlate with iloperidone response. Iloperidone achieved statistical significance over placebo on the PANSS scale in these patients, with a magnitude of response greater than that seen in the overall iloperidone population.

The trial was a randomized, double-blind, placebo-controlled, multicenter, four-week inpatient study that enrolled 604 patients with schizophrenia. The trial examined iloperidone 12 mg dosed twice daily.