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FDA Approves Fesoterodine Fumarate, a New Drug to Treat Overactive Bladder
"Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest," said George Benson, M.D., deputy director, Division of Reproductive and Urologic Products at the FDA’s Center for Drug Evaluation and Research. "This new drug will provide an additional treatment option to help them manage problems with an overactive bladder."
Toviaz will be available by prescription only, as an extended release tablet in either 4 mg or 8 mg dosage strengths. It is to be administered once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults.
The safety and effectiveness of Toviaz were studied in two, 12-week, randomized controlled studies of the 4 mg and 8 mg doses. For the combined studies, a total of 554 patients received placebo, 554 patients received Toviaz 4 mg daily, and 566 patients received the drug 8 mg daily. The majority of patients were female with a mean age of 58 years. Toviaz is not approved for pediatric use.
In each of those two studies, the product showed a statistically significant and clinically meaningful improvement in decreasing the number of times patients needed to urinate per day, as well as the number of urine leaking episodes they experienced per day, as compared to placebo.
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 is not recommended in doses above 4 mg in those patients with severe reduction in kidney function or in those patients taking medications, such as ketoconazole, that block the metabolism of the drug. It should not be used in patients who suffer from urinary or gastric retention or in patients with uncontrolled, narrow-angle glaucoma. It should also not be used in patients with severe liver impairment. The product should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
- Online: www.fda.gov/MedWatch/report.htm
- Regular mail: Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: (800) FDA-0178
- Phone: (800) FDA-1088
Source: Food and Drug Administration