The phase II pagoclone trial enrolled approximately 130 patients and will be the largest controlled pharmaceutical trial ever conducted in stuttering. The trial is an eight-week, double-blind, placebo-controlled study evaluating the improvement in stuttering in adults receiving pagoclone versus placebo. Data is expected to be reported by the middle of June.
The Sanctura XR trial meanwhile, is the first of two phase III trials and contains approximately 600 patients. Enrollment of the second trial is expected to be completed within the next 60 days. Both phase III trials are 12-week, double-blind, placebo-controlled studies, evaluating the effect of Sanctura XR in reducing frequency, urgency, and incontinence episodes in patients with overactive bladder.
Sanctura XR is the once daily formulation of Sanctura, which is currently marketed for overactive bladder. Indevus expects to report data on the first Sanctura XR trial by the end of June and to file a new drug application for the drug candidate with the FDA by the end of 2006.