New Overactive Bladder Drug Approved

Can you imagine your whole day revolving around where the nearest restroom is? Overactive Bladder syndrome (OAB) suffers may have frequent sudden urges to urinate even when their bladders aren’t full, which may lead them to constantly being aware of the nearest restroom. It seems OAB can affect up to one in every six Americans.

Overactive bladder sufferer’s lives are affected in so many ways. Imagine being a school teacher, school bus driver, or public transportation driver and suffering from OAB. You may no longer be able to continue working in your current career, if able to work at all, due to OAB, unless proper treatment is found. Adults suffering from OAB will soon have a new drug option available. The United States FDA recently approved a new prescription drug, Toviaz (generically known as fesoterodine fumarate), to treat overactive bladder symptoms in adults.

Topiaz is a German drug manufactured by Schwarz Pharma and distributed by Pfizer Inc. Its recent FDA approval was based on results from two studies, each lasting over a twelve week period. 554 patients were involved in the studies, and they either took a 4-milligram dose, an 8-milligram dose or a placebo tablet daily. Toviaz reduced OAB symptoms significantly compared to the placebo. The new drug works to reduce symptoms, such as urinary frequency, the urge to urinate, and sudden urinary incontinence, by relaxing the smooth muscle tissues of the bladder, according to the FDA.

Toviaz will be available by prescription only, as an extended release tablet to be taken once daily in early 2009. The new drug will be available in 4 or 8 mg dosage strengths. It is recommended for patients to start with the lower dose and increase to the larger dose only if needed, depending on individual patient’s response to the lower dose and tolerability. The drug should not be prescribed to patients with severely decreased liver function and those with narrow-angle glaucoma that is out of control.

Based on research, Toviaz may cause some side effects including constipation, dry mouth and a few cases reported dry eyes, and trouble emptying the bladder. There are several treatments for Overactive Bladder Syndrome, such as bladder retraining, diet modification, drugs, neurmodulation and as a last resort, surgery. The other drug treatments already on the market used to treat OAB syndrome include Sanctura by Allergan and Oxytrol by Watson Pharmaceutical’s.

George Benson the Deputy Director of the Division of Reproductive and Urologic Products, at the FDA's Center for Drug Evaluation and Research said, "Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest," but there is help on the way. "This new drug will provide an additional treatment option to help them manage problems with an overactive bladder."