The FINANCIAL -- Pfizer announced that a
Phase 4 study assessing the efficacy and safety of Toviaz 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 , 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. According to Pfizer Inc., 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 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.
“This study adds to the body of evidence supporting Toviaz as an effective treatment for patients with overactive bladder, including patients who may not have responded to Detrol LA,” said study principal investigator Dr. Steven A. Kaplan, professor of urology, Weill Cornell Medical College and director of the Iris Cantor Men’s Health Center at New York Presbyterian/Weill Cornell Medical Center in New York. “Health care 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.”
Overactive bladder is a treatable medical condition often 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 American adults are estimated to suffer from OAB symptoms. Despite its prevalence, overactive bladder is often unrecognized and untreated.