The U.S. Food and Drug Administration (FDA) has approved Toviaz, extended relief tablets - a new prescription drug to treat overactive bladder (OAB) in adults.
Toviaz (fesoterodine fumarate) works by relaxing the bladder’s smooth muscle tissue, thereby reducing urinary frequency and leakage of urine which are classic symptoms of OAB.
Overactive bladder is a bothersome medical condition affecting more than one in six Americans, yet it still remains highly under treated.
Toviaz, available by prescription only, is taken once-daily in doses of 4 or 8 milligrams. Typical starting dosage is 4 mg, which can be increased to 8 mg, based on patient response and tolerability, according to the FDA.
The safety and effectiveness of Toviaz was studied in two large 12-week Phase III clinical studies of 1,964 OAB patients. Patients showed up to an 88 percent median reduction in urinary incontinence with Toviaz 8 mg versus 50 percent with placebo.
Treatment with Toviaz 8 mg showed a statistically significant improvement in lessening the amount of times patients needed to urinate daily (up to 19 percent), as well as the number urine leaking episodes experienced each day, compared to the placebo (11 percent).
Common side effects of use include: dry mouth and constipation, according to the FDA. Less commonly reported side effects include trouble emptying the bladder and dry eyes.
Toviaz in dosages higher than 4 mg is not recommended for patients with severe reduction in kidney function or those people taking medications, such as ketoconazole, that block metabolism of Toviaz.
Some people should not Toviaz, including patients with severe liver impairment, gastric retention or uncontrolled, narrow-angle glaucoma, the FDA said.
Any serious adverse events (side effects) can be reported by consumers and/or health care professionals to the FDA’s MedWatch Adverse Event Reporting Program.
Toviaz is made by Schwarz Pharma and distributed by Pfizer. It is expected to be available in the U.S. in early 2009. #