FDA approves once-daily treatment for overactive bladder

November 20, 2008

The FDA has approved fesoterodine fumarate (Toviaz) extended-release tablets for the treatment of overactive bladder symptoms.

The FDA has approved fesoterodine fumarate (Toviaz) extended-release tablets for the treatment of overactive bladder symptoms.

Available in 4 mg and 8 mg doses, the once-daily agent can significantly reduce the number of urge urinary incontinence episodes and the frequency of urination over 24 hours, according to Pfizer, the drug’s manufacturer.

“Clinical trials with fesoterodine fumarate showed strong efficacy and favorable tolerability, and the ability to titrate the dose of [the drug] allows physicians flexibility in treating each patient based on individual history and need,” said Victor Nitti, MD, of New York University, who is a principal investigator for fesoterodine.

The approval is based on two 12-week, phase III clinical studies of 1,964 overactive bladder patients. In these studies, patients showed up to an 88% median reduction in urge urinary incontinence with fesoterodine, 8 mg, versus 50% with placebo. Treatment with fesoterodine, 8 mg, reduced the number of urinations per day by up to 19% compared with 11% with placebo treatment. Reductions in wetting accidents with fesoterodine were seen as early as week 2 of treatment and were maintained over 12 weeks.

The most commonly reported adverse event was mild to moderate dry mouth (incidence of 7% for placebo, 19% for fesoterodine, 4 mg, and 35% for fesoterodine, 8 mg).