US regulators on Friday approved Toviaz (fesoterodine fumarate) for patients suffering from overactive bladder. The drug is made by Germany’s Schwarz Pharma and distributed in the US by Pfizer Inc of New York.

“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,” said George Benson, deputy director, Division of Reproductive and Urologic Products at the FDA's Center for Drug Evaluation and Research.

The drug works by relaxing the smooth tissue of the bladder, reducing this way the urinary frequency, urge to urinate, and sudden urinary incontinence, the most significant symptoms of overactive bladder.

The approval is based on the results of two studies, each lasting 12 weeks. The studies involve 554 patients who were given the 4-milligram dose, the 8-milligram dose or a placebo. Patients taking Toviaz felt significantly better as the drug reduced urinary frequency.

However, the drug has some negative side effects such as dry mouth, constipation and dry eyes, therefore, it should not be prescribed for patients suffering from constipation, patients with severe liver impairment or uncontrolled, narrow-angle glaucoma, the FDA said.

Also, the drug is not recommended for patients with severe reduced kidney function or people taking medications, such as ketoconazole, that block metabolism of Toviaz.

Patients prescribed the drug may report any side effects or product quality problems with Toviaz to the FDA’s MedWatch Adverse Event Reporting program.