The company reported the completion of enrollment in the first of its two phase III trials earlier this month. Consistent with previous guidance, the company expects to file a new drug application with the FDA by the end of the calendar year.
The second of the two phase III trials has enrolled over 560 patients and the company anticipates reporting results in July of 2006. 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 is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The most commonly reported side effects in phase III US clinical trials were dry and constipation.