The U.S. Food and Drug Administration has approved a new prescription drug, Toviaz (fesoterodine fumarate), to treat overactive bladder in adults. Overactive bladder (OAB) in adults is characterized by urinary frequency and sudden urinary incontinence, Toviaz relaxes the bladders smooth muscle tissue reducing the urge to urinate.

George Benson, MD, deputy director of the Division of Reproductive and Urologic Products at the FDA's Center for Drug Evaluation and Research said, "Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest. This new drug will provide an additional treatment option to help them manage problems with an overactive bladder."

Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed by Pfizer Inc. of New York, N.Y. and is to be taken once daily. The prescription drug will be available as an extended release tablet in doses of 4mg or 8 mg strength. The starting dose is recommended as the 4 mg one which can be increased to 8 mg depending on the individual response and tolerability.

The drug is only approved for adults and the FDA gave its approval based on the results of two studies each of 12 week duration. A total of 554 patients were studied in both the studies with some getting the 4 mg drug, some the 8 mg and others a placebo. Toviaz reduced the number of times per day that the patient felt the need to urinate or leaked urine.

The FDA said common side effects of the drug include dry mouth and constipation. Dry eyes and trouble emptying the bladder are less frequently reported side effects of Toviaz.

The drug is not recommended for patients who suffer from urinary or gastric retention, patients with uncontrolled, narrow-angle glaucoma, or patients with severe liver impairment. Patients with decreased gastrointestinal motility, such as those with severe constipation should use Toviaz with caution.