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Patients who suffer from overactive bladder can now hope for better as the FDA approved a new prescription drug called Toviaz that deals with overactive bladder in adults. Two 12-week randomized placebo-controlled studies, involving a total of 554 patients, found that the drug reduced urinary frequency, urge to urinate, and sudden incontinence. The FDA said it approved Toviaz based on the results of these two studies involving more than 1,000 patients with the disorder.
Toviaz, made by German manufacturer Schwarz Pharma, helps relax the bladder muscles, reducing the urge to urinate and accidental leakage. New York-based Pfizer will distribute the once-a-day pill.
However the pill has certain side effects such as dry mouth, constipation and dry eyes. That’s why some people should not use the drug, including patients with severe liver impairment or uncontrolled, narrow-angle glaucoma, the FDA said.
George Benson, MD, 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. This new drug will provide an additional treatment option to help them manage problems with an overactive bladder."
Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed by Pfizer Inc. of New York, N.Y. The prescription drug will be available as an extended release tablet in doses of 4mg or 8 mg strength. The starting dose is recommended as the 4 mg one which can be increased to 8 mg depending on the individual response and tolerability.
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