Positive Phase III Results for Fesoterodine Released

The results of Schwarz Pharma's Phase III trials with fesoterodine for the treatment of overactive bladder syndrome have demonstrated statistically significant improvements in symptoms.

Schwarz Pharma announced that the efficacy results showed improvements compared to placebo in all primary variables requested by both the FDA and the European regulatory authorities. More than 90 percent of patients chose to enter the open-label trials that followed.

In this double-blind, placebo-controlled program conducted in the U.S. and in Europe, the efficacy, tolerability and safety of fesoterodine were studied. A total of approximately 1,900 patients were randomized and began a two-week placebo run-in phase followed by a 12-week treatment period.

The primary variables were change in average number of micturitions per 24 hours, change in average number of urge incontinence episodes per 24 hours and treatment response, derived from a treatment benefit scale. Patients received placebo, 4 mg or 8 mg fesoterodine once daily. In the European trial, one additional group received 4 mg tolterodine ER (extended release), once daily. The results of the European trial indicate a favorable profile of fesoterodine over tolterodine ER.