Novartis and Vanda Pharmaceuticals reported positive results from a phase III trial of iloperidone for the treatment of akathisia in schizophrenia. This randomized, double-blind, placebo controlled trial enrolled 706 subjects who were placed into one of four treatment groups: iloperidone 12.16 mg/d or 20.24 mg/d, risperidone 6.8 mg/d or placebo for 6 weeks. Changes in akathisia were measured weekly by the Barnes Akathisia Scale (BAS) and the Extrapyramidal Symptom Rating Scale (ESRS) from baseline to the six-week end point.
Both iloperidone groups had fewer subjects whose total akathisia score worsened (12%, p=0.04; 8%, p=0.004, respectively), compared to placebo and risperidone (20%, p=1.00). In addition, anticholinergic medication was needed for extrapyramidal symptoms in 5% and 7% of the two iloperidone dose groups respectively, compared with 22% for risperidone and 7% for placebo. The results were presented at the 2007 American Psychiatric Association annual meeting.
Vanda licensed iloperidone in 2004 from Novartis Pharma AG and is completing the phase III program. Based on the results, the Vanda expect to file a NDA in Q4 of 2007.