New data on Vesicare show significant improvements in urgency for patients with overactive bladder

Vesicare is the first overactive bladder treatment at an approved dose to show a statistically significant increase in warning time before urination

Christchurch, New Zealand – December 1, 2006 – Patients with overactive bladder (OAB) treated with VESIcare® (solifenacin succinate) experienced statistically significant reductions in episodes of urgency (the sudden, compelling need to urinate), according to a new study presented today at the 36th Annual Meeting of the International Continence Society.

A secondary endpoint from this study also presented today demonstrated that patients taking VESIcare experienced a statistically significant increase in warning time – compared with patients taking placebo (31.5 seconds vs. 12.0 seconds median increase, respectively; p<0.03). In this study warning time was defined as the time from the first sensation of urgency to voiding (going to the bathroom). VESIcare is the first OAB treatment at an approved dose to show a statistically significant increase in warning time.

"Urgency is generally considered to be the most important symptom for patients suffering from OAB," said Marc Toglia, MD, Urogynecology Associates of Philadelphia. "Increasing the time interval between the first sensation to void and the act of voiding may be an important goal as it could reduce the likelihood of a patient experiencing an incontinent episode."

VENUS Study Findings

VENUS (VESIcare Efficacy and Safety in PatieNts with Urgency Study) was a randomized, double-blind, placebo-controlled, parallel-group, flexible-dosing, multicenter study designed to assess the efficacy of VESIcare on urgency symptoms in patients (n=739) with OAB. Patients received either 5 mg VESIcare or placebo daily for the first four weeks of the study. At weeks four and eight, the dose of VESIcare (or matching placebo) could be maintained, increased to 10 mg/day, or decreased to 5 mg/day. Changes in OAB symptoms including urgency, frequency, and incontinence were measured via 3-day micturition (acts of urination) diaries. Patients' perceptions of urgency were assessed using the Indevus Urgency Severity Scale (IUSS) and the Urgency Perception Scale (UPS). Warning time was measured using a stopwatch.

At the end of the 12-week study the primary endpoint of mean change in urgency episodes per 24 hours had decreased by 3.91 for patients treated with VESIcare (n=348) compared with 2.73 (p<.0001) for patients receiving placebo (n=336). In a secondary endpoint, using the IUSS, more patients taking VESIcare who had described their urgency as "moderate" or "severe" at baseline assessed it as "mild" or "moderate" at the end, compared with placebo (58.1% vs. 41.7%). More patients taking VESIcare reported improvements in their degree of urgency on the UPS as well compared to placebo (42.1% vs. 33.1%).

For this study the most common drug-related, treatment-emergent adverse events reported were dry mouth (25.3%, 9.0%), constipation (14.8%, 9.3%), blurred vision (3.8%, 1.1%), dizziness (3.2%, 1.9%), and fatigue (2.7%, 1.1%) with VESIcare 5 mg or 10 mg and placebo, respectively.

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About Overactive Bladder

Overactive bladder affects an estimated 17 million men and women in the United States, yet many mistakenly believe it cannot be treated. For people with OAB, inappropriate signals are sent to the muscles in the bladder causing them to contract before the bladder is full. These bladder contractions may cause strong, sudden urges, and a frequent need to go to the bathroom, sometimes without any advance warning. Many patients cope with their symptoms by restricting fluids, carrying extra clothing, and "mapping" bathroom locations wherever they go. Some patients even curtail their social activities for fear of an embarrassing leaking accident.

The effects of OAB take 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.

About VESIcare® (solifenacin succinate)

VESIcare is for urgency, frequency, and leakage (overactive bladder). VESIcare is not for everyone. Patients should not take VESIcare if they have certain types of stomach, urinary, or glaucoma problems. While taking VESIcare, if patients experience a serious allergic reaction, severe abdominal pain, or become constipated for three or more days, they should tell their doctor right away. In studies, common side effects were dry mouth, constipation, blurred vision, and indigestion.

The recommended dose of VESIcare is 5 mg once daily. If the 5-mg dose is well tolerated, the dose may be increased to 10 mg once-daily.

As with other anticholinergic agents, VESIcare is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.

As with other anticholinergic agents, VESIcare should be administered with caution to patients with bladder outflow obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function.

Doses of VESIcare higher than 5 mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients with severe hepatic impairment is not recommended.

The most common adverse events reported by patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%, 1.8%) and dyspepsia (1.4%, 3.9%, 1.0%) with VESIcare 5mg, 10mg, and placebo, respectively.

The overall rate of serious adverse events was 2%. For the 10 mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction and one intestinal obstruction). For the 5 mg dose, one case of angioneurotic edema was reported.

For complete prescribing information for VESIcare, go to www.vesicare.com.

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.com/us.

About GlaxoSmithKline

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For more information, please visit the company's Web site at www.gsk.com.

For more information or full prescribing information, contact:

GlaxoSmithKline:
Marc Meachem, Product Communications: 919-483-8756

Astellas:
Maribeth Landwehr, Corporate Communications: 847-317-8988


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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