Iloperidone demonstrated statistically significant improvement compared with placebo on the trial's primary endpoint, the company said in a press release.
"We will be filing with the FDA by end of 2007 and this drug can be on the market as early as the beginning of 2009," said Dr. Michael Polymeropoulos, Vanda Pharmaceuticals CEO, appearing on CNBC's Squawk Box.
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 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% of patients, hypothesized to be associated with the pathogenesis of schizophrenia which
appeared to correlate with iloperidone response.
Iloperidone achieved statistical significance vs. placebo on the PANSS scale in these patients,
with a magnitude of response greater than that seen in the overall iloperidone population.
The Phase III trial was a randomized, double-blind, placebo-controlled, multi-center, 4 week inpatient study that enrolled 604 patients with schizophrenia. The trial examined iloperidone 12 mg dosed twice-daily, or 24 mg per day. The primary endpoint was efficacy vs. placebo in PANSS (total) using the Mixed Method Repeated Measures (MMRM) methodology. The secondaryendpoint was efficacy in the genetic subpopulation.