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news.Vanda Pharmaceuticals has reported that positive data from four Phase III efficacy and safety trials demonstrate that iloperidone, an investigational atypical antipsychotic, is associated with greater improvements in schizophrenia symptoms compared to placebo and has a favorable safety and tolerability profile.
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The Phase III study evaluated the efficacy of iloperidone versus placebo in patients with schizophrenia. The study was a randomized, double-blind, placebo-controlled, multi-center, four-week inpatient study that enrolled 604 patients. Following fixed-dose titration, inpatients were randomized to receive iloperidone at 24mg/day, ziprasidone at 160mg/day, or placebo. Patients treated with iloperidone had significantly greater improvements in positive and negative syndrome scale-total (PANSS-T) scores than those on placebo, and had PANSS-T improvement comparable to ziprasidone.
Iloperidone and ziprasidone showed similarly low effects on glucose, cholesterol, triglyceride and prolactin levels compared to placebo. Iloperidone also had a similar akathisia profile to placebo, whereas ziprasidone was associated with a worsening of akathisia versus placebo on the barnes akathisia scale (BAS), with 26% of patients experiencing a worsening of akathisia. Iloperidone was also associated with a favorable profile on the extrapyramidal symptoms rating scale (ESRS) versus placebo.