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Titan’s schizophrenia drug exhibits efficacy and safety

Titan Pharmaceuticals has reported that data from four Phase III efficacy and safety trials demonstrate that iloperidone, an investigational atypical antipsychotic, is associated with significantly greater improvements in the symptoms of schizophrenia versus placebo and has a favorable safety and tolerability profile.

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, and iloperidone was also associated with a favorable profile on the extrapyramidal symptoms rating scale (ESRS) versus placebo.