Saturday November 1, 2008 (foodconsumer.org) – The U.S. Food and Drug Administration announced on Friday that it had approved a new treatment called Toviaz (fesoterodine fumarate) to help patients suffering from overactive bladder or OAB.

Overactive bladder (OAB) is a urological condition that causes abnormal urination with symptoms including increased urinary frequency, urge to urinate and leakage of urine.

Toviaz manufactured by Schwarz Pharma of Zwickau, Germany and distributed by Pfizer Inc. of New York, N.Y. works by relaxing the smooth muscle tissue of the bladder, according to the FDA.

Common treatments for OAB include diet modification, bladder retraining, antimuscarinic drugs and various devices, wikipedia says.   Intravesical botulinum toxin A is also used in some cases although the FDA did not formally approve the therapy.

"This new drug will provide an additional treatment option to help them manage problems with an overactive bladder." said George Benson, M.D., deputy director, Division of Reproductive and Urologic Products at the FDA’s Center for Drug Evaluation and Research.

Toviaz will be available by prescription only for adults, sold in forms of tablets with 4 mg or 8 mg dosages and administrated once a day, the FDA said.

The drug was approved based on data on its safety and efficacy obtained from two 12-week trials of a total more than 1500 patients of whom the majority was female and aged 58 years on average.

The FDA said in its announcement that in each of those two studies, Toviaz showed statistically significant and clinically meaningful improvement in decreasing the number of times patients needed to urinate per day and also the number of urine leaking episodes each day.

Like all medications, Toviaz causes side effects including dry mouth and constipation, less commonly dry eyes and trouble emptying the bladder.

The FDA warned that this medication is not recommended in doses above 4 mg for patients with severe reduction in kidney function, those patients taking certain medications and those who suffer from decreased gastrointestinal motility, such as those with severe constipation.