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Vesicare (Solifenacin Succinate) Now Available in the United States

New Option for Men and Women Suffering from Overactive Bladder Symptoms -

PARAMUS, NJ and RESEARCH TRIANGLE PARK, NC -- January 19, 2005 -- Vesicare® (solifenacin succinate) tablets, a new prescription medication for the treatment of overactive bladder (OAB), is now available in pharmacies nationwide. Vesicare, taken once daily, treats all the major symptoms of OAB including urgency, frequency and urge incontinence.

"A big fear for patients is having an embarrassing accident caused by their OAB symptoms," said Peter Sand, MD, Director of Urogynecology, Northwestern University. "The availability of Vesicare as a new once-daily treatment option will help those men and women who suffer from symptoms like incontinence."

OAB is a medical condition that causes the bladder muscle (known as the detrusor muscle) to contract while the bladder is filling with urine, rather than when the bladder is full. This results in a patient experiencing urgency (an immediate and strong sense to urinate), frequency (the need to frequently go to the bathroom), and for many, urge incontinence (an involuntary loss of urine).

Vesicare was approved by the U.S. Food and Drug Administration (FDA) in November 2004, and was found to significantly reduce the number of incontinence episodes for patients over 12-weeks. In clinical studies involving more than 3,000 patients with symptoms of urgency, frequency and/or urge incontinence, once-daily Vesicare 5 mg and 10 mg showed statistically and clinically significant improvement in all major symptoms of OAB during a 12-week study period.

"I used to find ways of coping with the chance of embarrassing leakage, like restricting my fluids and even carrying extra clothing with me, but it wasn't enough for me-I still worried I might have an accident," said Shirley Infinger, who has suffered from incontinence associated with OAB for many years. "With Vesicare, I am taking the steps to do something more about the problem instead of dealing with it on my own. I'm relieved to have finally talked to my doctor."

While OAB affects more than 17-20 million men and women in the U.S., few understand that it is a treatable condition. Many mistakenly believe it is a natural part of aging, are embarrassed to discuss it, or believe there is no treatment option available. Therefore, patients gradually develop coping behaviors to manage their symptoms, including "mapping" bathroom locations, or even choosing not to leave the house. OAB exacts not only a physical, social and emotional toll on patients but a financial one as well, with estimated costs of nearly $14 billion in the U.S. in 2000.

About Vesicare
Vesicare is for urgency, frequency, and leakage (overactive bladder). Vesicare is not for everyone. If patients have certain types of stomach, urinary or glaucoma problems, they should not take Vesicare. While taking Vesicare, if patients experience severe abdominal pain or become constipated for three or more days, they should speak to their doctor. In studies, the most common side effects were dry mouth, constipation, and blurred vision.


SOURCE: Yamanouchi Pharmaceutical Co., Ltd.; GlaxoSmithKline

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