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Pfizer Inc.
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.
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