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| |  Ditropan XL Reduces Urge Incontinence Episodes By 85% MONTE CARLO, MONACO -- June 29, 1998 -- Patients treated with Alza Corp.’s Ditropan(R) XL -- a once-daily formulation of oxybutynin chloride under development for the treatment of urge urinary incontinence -- achieved continence or significant symptomatic improvement and experienced nearly 50 percent less incidence of moderate or severe dry mouth compared to patients treated with immediate-release oxybutynin, according to results from a randomised, double-blind Phase III clinical study. The study is being presented at the World Health Organization's first International Consultation on Incontinence, held this week in Monaco. In a study of 105 patients at 13 U.S. centres, 24.5 percent of patients treated with Ditropan XL reported side effects of moderate or severe dry mouth, compared to 46.1 percent of patients treated with the immediate-release drug. More than 42 percent of patients treated with Ditropan XL achieved complete continence. The number of urge incontinence episodes for all patients treated with Ditropan XL was reduced by 85 percent, from an average of 27 accidents per week before treatment to four per week. Immediate-release oxybutynin is the most widely prescribed drug for the treatment of urge urinary incontinence in the United States. Alza submitted a New Drug Application for Ditropan XL to the U.S. Food and Drug Administration in December 1997. An estimated five to eight million people in the U. S. suffer from urge urinary incontinence, a disorder characterised by sudden, involuntary bladder contractions that lead to the loss of bladder control. Symptoms of urge incontinence include frequent urination, urgency (the need to urinate immediately) and incontinence (accidents). Urge incontinence also may cause sleep disturbances, depression and skin disorders.
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