Pfizer Inc. (NYSE: PFE) announced today that a Phase 4 study assessing the efficacy and safety of Toviaz(R) (fesoterodine fumarate) in patients with overactive bladder (OAB) met its primary endpoint. Toviaz reduced urge urinary incontinence (UUI) in patients with OAB who had a suboptimal response (less than 50 percent reduction in UUI) to Detrol LA (tolterodine tartrate extended release), a commonly-prescribed treatment for the condition. UUI is the involuntary leakage of any amount of urine, associated with or immediately preceded by a sense of urgency.
The 14-week randomized, parallel group, placebo-controlled, double-blind multicentre study assessed Toviaz 8 mg in patients with OAB who had been taking Detrol LA 4 mg for two weeks and had less than 50 percent reduction in urge urinary incontinence episodes. After open-label treatment with Detrol LA 4 mg, treatment with Toviaz 4 mg was started for one week, followed by treatment with Toviaz 8 mg.
The study demonstrated that Toviaz 4 mg for one week followed by Toviaz 8 mg statistically significantly reduced the average number of urge urinary incontinence episodes (-2.37 episodes from baseline) per 24 hours (p<0.0001) in OAB patients who had a suboptimal response to Detrol LA 4 mg. The safety and tolerability profiles of fesoterodine and tolterodine were consistent with previous studies. The most common treatment-emergent adverse events for both fesoterodine and tolterodine were dry mouth and constipation. Further analyses will be conducted and a publication of the comprehensive results is planned at a later date.(c) 2012 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.