FDA approves new oral treatment for overactive bladder

November 24, 2004

The FDA has approved the anticholinergic agent solifenacin succinate (Vesicare) for the treatment of overactive bladder with symptoms of urgency, frequency, and urge incontinence.

The FDA has approved the anticholinergic agent solifenacin succinate (Vesicare) for the treatment of overactive bladder with symptoms of urgency, frequency, and urge incontinence.

In clinical studies, investigators found that both 5-mg and 10-mg doses of solifenacin statistically and clinically improved all major symptoms of overactive bladder, including a significant reduction in the number of incontinence episodes during a 12-week study period compared with placebo (p<.001).

Solifenacin has a half-life of 50 hours. In studies, it demonstrated 24-hour control of OAB symptoms.

The recommended dose is 5 mg once-daily.

In studies, the most common side effects were dry mouth (5 mg, 10.9%; 10 mg, 27.6% vs. placebo, 4.2%); constipation (5 mg, 5.4%; 10 mg, 13.4% vs. placebo, 2.9%); and blurred vision (5 mg, 3.8%; 10 mg, 4.8% vs. placebo 1.8%).