The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. “Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest,” said George Benson, M.D., deputy director, Division of Reproductive and Urologic Products at the FDA’s Center for Drug Evaluation and Research. “This new drug will provide an additional treatment option to help them manage problems with an overactive bladder.” Toviaz will be available by prescription only, as an extended release tablet in either 4 mg or 8 mg dosage strengths. It is to be administered once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults. The safety and effectiveness of Toviaz were studied in two, 12-week, randomized controlled studies of the 4 mg and 8 mg doses. For the combined studies, a total of 554 patients received placebo, 554 patients received Toviaz 4 mg daily, and 566 patients received the drug 8 mg daily. The majority of patients were female with a mean age of 58 years. Toviaz is not approved for pediatric use. In each of those two studies, the product showed a statistically significant and clinically meaningful improvement in decreasing the number of times patients needed to urinate per day, as well as the number of urine leaking episodes they experienced per day, as compared to placebo.
