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| |  Ditropan XL Now Available In U.S. For Overactive Bladder PALO ALTO, CA -- Feb. 1, 1999 -- Alza Corp.’s Ditropan(R) XL (oxybutynin chloride), the first once-a-day treatment for overactive bladder, is now available in the United States. Ditropan XL couples a proven therapeutic with a leading drug delivery technology to help reduce the discomfort and embarrassment often associated with symptoms of overactive bladder. Although overactive bladder is most prevalent among women and older adults, the condition can affect people of all ages. It is characterised by urge urinary incontinence (sudden and involuntary loss of bladder control resulting in wetting accidents), urgency (the urgent need to empty the bladder) and frequency (frequent urination). These symptoms can interfere with some of the most basic daily activities, such as exercising, travelling and sleeping and may restrict social interactions with families and friends. In fact, many people with overactive bladder become socially isolated or even housebound because they fear the embarrassment of having wetting accidents in public. "Overactive bladder can have a profoundly negative impact on a patient's life, yet many patients don't realise overactive bladder is a treatable condition," said Rodney Appell, M.D., head of the section of voiding dysfunction and female urology, the Cleveland Clinic Foundation. "Ditropan XL is an effective and generally well-tolerated therapy that can help many patients experience a significant reduction in symptoms. In addition, once-a-day dosing makes it easier for patients to comply with their treatment regimen." Overactive bladder remains widely underdiagnosed and undertreated. In fact, an estimated 90 percent of patients with overactive bladder do not discuss the symptoms with their physician, primarily due to embarrassment, lack of self confidence and the common belief that overactive bladder is a normal part of aging. Many leading urologic and patient advocacy organisations have become increasingly vocal about the need for patients and healthcare professionals to better understand overactive bladder and its treatment. The efficacy and safety of Ditropan XL were demonstrated in 429 adult incontinent patients in three controlled studies and one open-label study. In these controlled studies, Ditropan XL demonstrated efficacy superior to placebo in the reduction of urge incontinence episodes, or wetting accidents. Patients treated with Ditropan XL experienced between 15 to 18 fewer urge incontinence episodes per week. In clinical trials, Ditropan XL was demonstrated to be generally well-tolerated by patients. The most common adverse events observed with Ditropan XL were those expected with anticholinergic agents, including dry mouth (61 percent overall; only one percent of patients discontinued the clinical trials due to dry mouth), constipation (13 percent), drowsiness (12 percent), diarrhea (nine percent), blurred vision (eight percent), dry eyes (six percent), dizziness (six percent) and runny nose (six percent). The incidence of dry mouth was dose-related. In all controlled trials, seven percent of patients treated with Ditropan XL discontinued because of adverse events. Ditropan XL combines conventional oxybutynin -- which has been prescribed for 6.5 million Americans for symptoms of overactive bladder -- with Alza's patented OROS osmotic technology. This technology is designed to improve oral drug administration by providing rate-controlled delivery of the drug, minimising the peak and trough concentrations associated with conventional medications. This results in more consistent therapeutic drug levels in the blood and reduces the number of times per day that the medication must be taken.
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