Pfizer Inc. has released the positive top-line results for Toviaz (fesoterodine fumarate) study A0221048 – effectiveness and safety of a flexible dose regimen for patients with overactive bladder including nocturnal urinary urgency.
The study met its primary endpoint, as treatment with Toviaz was found to be statistically significantly superior to placebo in reducing the mean number of urinary urgency episodes overnight during sleep hours after 12 weeks of treatment. Further analyses will be conducted on the initial data, including submission for publication of comprehensive results at a later date.
Overactive bladder is a treatable medical condition caused by involuntary contractions or spasms of the bladder muscle. Overactive bladder symptoms of urgency, frequency or urge urinary incontinence can be bothersome and can have a significant impact on important aspects of people’s lives. Approximately 33 million Americans are estimated to suffer from overactive bladder symptoms. Despite its prevalence, overactive bladder is often unrecognized and untreated.
“Many patients with overactive bladder experience frequent interruptions during sleep hours from urinary urgency, which can be very disruptive and bothersome. In this study, Toviaz demonstrated efficacy in reducing the number of nocturnal urgency episodes,” said Steven J Romano, MD, senior vice president, Head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc.
Study A0221048 was a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre trial to compare the efficacy and safety of a flexible dose regimen of fesoterodine to placebo in subjects with symptoms of overactive bladder, including nocturnal urinary urgency. The 12-week trial evaluated a total of 937 individuals at 108 sites in the US. After an initial 2-week period during which subjects received placebo treatment, subjects were randomized either to a fesoterodine 4 mg arm (463 subjects) or to placebo (474 subjects) if they had less than or equal to a 35% reduction in nocturnal urgency episodes. After 4 weeks of treatment, based on patient self-reporting, investigators could increase the daily dose of fesoterodine to 8 mg per day. The primary endpoint was change in mean number of nocturnal urinary urgency episodes per day at Week 12 relative to baseline. No significant safety concerns were identified, and the most common adverse events were dry mouth and constipation.