FDA approves Vesicare (solifenacin succinate) for the treatment of overactive bladder

Nov 23 2004

Vesicare (solifenacin succinate) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) with symptoms of urgency, frequency, and urge incontinence.

In clinical studies, Vesicare 5 mg and 10 mg showed clinical and statistical improvements in all symptoms of OAB. Specifically, once-daily Vesicare was found to significantly reduce the number of incontinence episodes for patients during a 12-week study period.

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. Patients with OAB feel the urge to urinate more often, without advance warning, and when the bladder isn't completely 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).

"A key concern for OAB patients is the very real fear of having an accident in public," said, Peter Sand, MD, Director of Urogynecology, Northwestern University. "The approval of Vesicare is important because it offers patients a treatment with a favorable safety profile that reduces symptoms-in particular the chance of accidental leaks."

While OAB affects an estimated 17-20 million men and women in the United States, few understand that it is a treatable condition. Many mistakenly believe this 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. These coping mechanisms include restricting fluids, carrying extra clothing, "mapping" bathroom locations, or even choosing not to leave the house. None of these behaviors, however, are clinically proven to be successful in treating the symptoms of OAB.

The debilitating effects of OAB exact not only a physical, social, and emotional toll on patients, but a financial one as well. It is estimated that costs related to OAB were nearly $14 billion in the United States in 2000, similar to that of gynecological and breast cancers, osteoporosis, or arthritis.