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FDA Approves Vesicare^® for the Treatment of Overactive Bladder

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.

OAB is a medical condition that causes the bladder 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 urge to urinate), frequency (the need to frequently go to the bathroom), and for many, urge incontinence (an involuntary loss of urine).

The approval of Vesicare was based on clinical findings from 4 double-blind, 12-week randomized, placebo-controlled, parallel group involving more than 3,000 patients with symptoms of urgency, frequency, and/or urge incontinence.

Clinical trial results:

• Once-daily Vesicare 5 mg and 10 mg showed statistically and clinically significant improvement in all major symptoms of OAB
• Reduction in the number of incontinence episodes was also significantly greater with Vesicare 5 mg and 10 mg compared to placebo
• Vesicare has approximately a 50-hour half-life. Also, once-daily Vesicare demonstrated 24-hour control of OAB symptoms.
• Across all 4 studies, the efficacy of once-daily administration of 5 mg and 10 mg of Vesicare was consistent across patient gender and age.

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