FDA Approves Toviaz, a New Drug to Treat Overactive Bladder

Toviaz (fesoterodine) was recently approved by the U.S. Drug and Food Administration for treating overactive bladder (OAB). Toviaz helps reduce symptoms of OAB including urinary frequency, urinary urgency, and urge urinary incontinence by preventing the contractions of urinary bladder smooth muscle. Toviaz is a prescription drug and it is available as an extended release tablet in two different dosage strengths (4 mg or 8 mg). Toviaz is administered at a recommended starting dose of 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. Toviaz is only approved for adults and its use in children has not been evaluated. The safety and effectiveness of Toviaz 4 mg and 8 mg were studied in two 12-week, randomized, controlled trials. In both trials, fesoterodine was found to improve overactive bladder symptoms; the findings were both statistically and clinically significant. Dry mouth and constipation were the most commonly reported adverse effects with other less common side effects including dry eyes and difficulty emptying the bladder. Doses above 4 mg are not recommended in patients with kidney dysfunction or in patients taking ketoconazole. Due to the pharmacological actions of Toviaz, it is contraindicated in patients with urinary or gastric retention, uncontrolled narrow-angle glaucoma, or severe liver impairment. Toviaz use is also not recommended in patients with intestinal problems such as constipation.

www.fda.gov

Prepared by Khanh-Ha Nguyen, PharmD. Candidate