WebMD Medical News
Brunilda Nazario, MD
Oct. 31, 2008 -- The FDA has approved a new prescription drug called Toviaz to treat overactive bladder (OAB) in adults.
Toviaz relaxes the bladder's smooth muscle tissue, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence 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. This new drug will provide an additional treatment option to help them manage problems with an overactive bladder," George Benson, MD, says in a news release. Benson is the deputy director of the Division of Reproductive and Urologic Products at the FDA's Center for Drug Evaluation and Research.
Toviaz, which is taken once daily, will be available as an extended-release tablet in doses of 4 or 8 milligrams. The recommended starting dose is 4 milligrams, which can be increased to 8 milligrams if needed, based upon individual response and tolerability, according to the FDA.
The FDA approved Toviaz based on two studies, each lasting 12 weeks. Together, the studies included 554 patients who took either the 4-milligram dose, the 8-milligram dose, or a placebo. Toviaz trumped the placebo at reducing the number of times per day that patients leaked urine or needed to urinate.
According to the FDA, common side effects associated with Toviaz included dry mouth and constipation. Less frequently reported side effects included dry eyes and trouble emptying the bladder.
Toviaz doses higher than 4 milligrams aren't recommended for patients with severe reduction in kidney function or people taking medications, such as ketoconazole, that block metabolism of Toviaz.
Toviaz shouldn't be used by patients who suffer from urinary or gastric retention, patients with uncontrolled, narrow-angle glaucoma, or patients with severe liver impairment. Toviaz should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.
Consumers or health care professionals may report any side effects or product quality problems with Toviaz to the FDA's MedWatch Adverse Event Reporting program.
Toviaz is made by Schwarz Pharma of Zwickau, Germany, and is distributed by the drug company Pfizer.
SOURCE:News release, FDA.
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