Iloperidone demonstrated statistically significant improvement compared to 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 phase III trials.
Vanda also evaluated iloperidone’s efficacy and safety in patients with specific genetic profiles. Vanda had previously identified a polymorphism in a gene, occurring in approximately 70% of patients, thought to be associated with the pathogenesis of schizophrenia which appeared to correlate with iloperidone response. Iloperidone achieved statistical significance compared to placebo on the PANSS scale in these patients, with a magnitude of response greater than that seen in the overall iloperidone population.
“The success of this trial moves us one step closer to our new drug application filing, expected in late 2007,” stated Paolo Baroldi, senior vice president of Vanda.