Iloperidone impresses in Ph III trial

18 December 2006

US biopharmaceutical firm Vanda Pharmaceuticals says that the results of a Phase III trial of iloperidone, its developmental atypical antipsychotic, indicate that the agent conferred significant symptom relief in schizophrenic patients. The firm explained that, patients who received the drug achieved improvement in both positive and negative symptom scores (PANSS).

The findings are based on data from a randomized, double-blind, placebo-controlled four-week study that enrolled 604 schizophrenic patients. Participants received 12mg of the drug twice daily, or placebo, with the primary endpoint defined as efficacy versus placebo in PANSS using the mixed method repeated measures methodology.

Vanda added that it had also assessed the agent's effect on the QT interval, prolongation of which is a well understood side effect of some atypical antipsychotics. The data illustrated that no patients treated with the drug experienced QT intervals of longer than 500 milliseconds, which is the Food and Drug Administration's defined threshold for concern.

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