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Primary Endpoint Met in Phase IV Study of Toviaz (Fesoterodine Fumarate) for Overactive Bladder
The 14-week randomized, parallel group, placebo-controlled, double-blind multicentre study assessed Toviaz 8 mg in 642 patients with OAB who had been taking Detrol LA 4 mg for 2 weeks and had less than a 50% reduction in UUI episodes. After open-label treatment with Detrol LA 4 mg, treatment with Toviaz 4 mg was started for 1 week, followed by treatment with Toviaz 8 mg.
The study demonstrated that Toviaz 4 mg for 1 week followed by Toviaz 8 mg significantly reduced the average number of UUI episodes (–2.37 episodes from baseline) per 24 hours (P
The safety and tolerability profiles of fesoterodine and tolterodine were consistent with previous studies. The most common treatment-emergent adverse events for both drugs were dry mouth and constipation.
Further analyses will be conducted, and a publication of the comprehensive results is planned for a later date.
Approximately 33 million American adults are estimated to have OAB symptoms.