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August 6, 2012

Pfizer OAB drug meets primary endpoint in Phase 4 study

Pfizer has reported positive results from a Phase 4 study evaluating the efficacy and safety of Toviaz (fesoterodine fumarate) in patients with overactive bladder (OAB).

Pfizer has reported positive results from a Phase 4 study evaluating the efficacy and safety of Toviaz (fesoterodine fumarate) in patients with overactive bladder (OAB).

In the study, which has met its primary endpoint, Toviaz reduced urge urinary incontinence (UUI) in patients with OAB who had a suboptimal response (less than 50% reduction in UUI) to commonly-prescribed therapy Detrol LA (tolterodine tartrate extended release).

The Iris Cantor Men’s Health Center at New York Presbyterian/Weill Cornell Medical Center director, Weill Cornell Medical College urology professor and study principal investigator Dr. Steven Kaplan said the study adds to evidence supporting Toviaz as an effective treatment for OAB patients, including those who have not responded to Detrol LA.

"Healthcare professionals often question how to treat patients who have had a suboptimal response to Detrol LA, which is commonly used but does not have a dose higher than 4 mg, and these data may help to guide treatment decisions," Dr. Kaplan added.

The 14-week randomised, double-blind multicentre study evaluated Toviaz 8mg in patients with OAB who had been taking Detrol LA 4mg for two weeks.

The study treatment started with 4mg/day of fesoterodine or matching placebo for one week. After the first week of treatment, the dose increased to 8mg/day of fesoterodine.

The study found that Toviaz 4mg for one week followed by Toviaz 8mg reduced the average number of urge urinary incontinence episodes per 24 hours (p<0.0001) by a statistically significant amount (-2.37 episodes from baseline) in OAB patients who had a suboptimal response to Detrol LA 4mg.

The parallel group, a placebo-controlled study, demonstrated consistent safety and tolerability profiles of fesoterodine and tolterodine compared to previous studies and reported dry mouth and constipation as common side effects.

 

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