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| |  Ditropan XL Approved For Treatment Of Overactive Bladder PALO ALTO, CA -- Dec. 17, 1998 -- The United States Food and Drug Administration has approved Alza Corp.’s Ditropan(R) XL (oxybutynin chloride), the first and only once-a-day treatment for overactive bladder. Ditropan XL provides control of overactive bladder for many patients -- treating the symptoms of urge urinary incontinence, urgency and frequency -- and has been demonstrated to significantly reduce the incidence of urinary accidents. "In clinical trials, Ditropan XL demonstrated a statistically significant reduction in urge urinary incontinence episodes, with a low dropout rate due to side effects," said Rodney Appell, M.D., head of the section of voiding dysfunction and female urology, the Cleveland Clinic Foundation. "This is due to the unique characteristics of oxybutynin which, as both an antimuscarinic and an antispasmodic agent, exhibits multiple effects on the bladder. To date, nothing has been proven more effective than oxybutynin in the treatment of overactive bladder." An estimated 17 million Americans suffer from overactive bladder – a common, treatable and chronic condition characterised by symptoms of 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). The condition is most prevalent among women and older adults. Ditropan XL provides an effective and well-tolerated therapy for symptoms of overactive bladder by coupling proven medicine and technology. The new treatment combines conventional oxybutynin -- the most commonly prescribed therapy for overactive bladder symptoms -- with ALZA's patented Oros osmotic technology. This technology is designed to improve oral drug administration by providing rate-controlled delivery of drug and reducing the number of times per day that the medication must be taken. "The use of Oros technology changes the profile of the active agent and allows Ditropan XL to provide consistent levels of medication throughout the day, minimising the peak and trough concentrations associated with conventional oxybutynin," said Michael Chancellor, M.D., associate professor of urologic surgery, University of Pittsburgh School of Medicine. "The once-a-day dosing of Ditropan XL can be a significant benefit for patients, who may find it easier to comply with their treatment regimens." The efficacy and safety of Ditropan XL were demonstrated in 429 adult incontinent patients in three controlled studies and one open-label study. In the controlled studies, Ditropan XL demonstrated efficacy superior to placebo in the reduction of urge incontinent episodes, or urinary 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 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) and drowsiness (12 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. At present, overactive bladder is widely underdiagnosed and undertreated. In fact, only about 10 percent of patients with overactive bladder discuss this condition with their physician -- in part because of embarrassment and the myth that overactive bladder is a normal part of aging. Overactive bladder can have a profound impact on patients and disrupt daily routines and activities. Some patients may become socially isolated or even housebound because they fear the embarrassment of having urinary accidents in public.
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