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AUA MEETING: Ditropan XL Effective In Reducing Urinary Incontinence SAN DIEGO, CA -- June 1, 1998 -- Results of a Phase III clinical study of Alza Corp.’s once-daily formulation of oxybutynin chloride, Ditropan(R) XL, demonstrated that patients with urge urinary incontinence experienced an 83 percent reduction in urge incontinence episodes and more than 43 percent of patients achieved complete continence, as reported yesterday at the 93rd annual meeting of the American Urological Association. The safety and dose determination study was designed to evaluate urge incontinence episodes, complete continence, voiding frequency and safety in patients who had not previously received drug therapy for urge incontinence as well as those already on drug therapy. Results of the efficacy analysis of the study demonstrated that 43 percent of previously untreated patients and 45 percent of previously treated patients had complete continence at the end of the study, compared with a baseline of zero percent and 18 percent, respectively. Patients also reported improvements in symptoms, with an 83 percent reduction of urge incontinence episodes, 78 percent reduction in all incontinent episodes and a 15 percent reduction in voiding frequency. The study involved 256 patients with urge incontinence who received Ditropan XL at doses that were increased until an elimination of urge incontinence episodes was achieved or to a maximum tolerated dose. Eighty-three percent of patients chose final doses ranging between 5 mg/day and 20 mg/day. Patients remained at the final dose for one week as confirmation of dose level and then continued at the same dose for an additional 12 weeks. Ditropan XL was well tolerated by most patients, with more than 90 percent of patients reporting satisfaction with therapy. The overall incidence of moderate-to-severe dry mouth in the study was 23 percent. Two percent of all patients discontinued due to dry mouth, while an additional six percent discontinued the study due to other adverse events. "In this study, many patients treated with Ditropan XL were able to completely eliminate incontinence episodes, or accidents," said Donald Gleason, M.D., of the Urological Associates of Southern Arizona, who presented the data. "Incontinent episodes have a significant impact on patients, who may restrict social interactions with friends and decrease activities outside the home to avoid embarrassment." Immediate-release oxybutynin is the most widely prescribed drug in the treatment of urge urinary incontinence. Ditropan XL combines oxybutynin with Alza's proven oral drug delivery technology. ALZA submitted a New Drug Application (NDA) for Ditropan XL to the United States 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 which lead to the loss of bladder control. Symptoms include voiding frequency, urgency (need to urinate) and incontinence (accidents). The condition also may cause sleep disturbances, depression and skin disorders. More information on: Alza Corp. E-mail this page to a friend or colleague! To print, use this version