Watson Announces Positive Results From Its Pivotal Study of Oxybutynin Topical Gel for the Treatment of Overacti...(mong existing oral OAB treatments accord...),Health

The Phase 3 multi-center, double blind, placebo-controlled study evaluated the efficacy and safety of OTG in 789 patients with overactive bladder. The primary objective of the study was to demonstrate that daily treatment of a 1g dose (approximately 1 mL) of OTG for 12 weeks was superior to placebo for the relief of OAB symptoms. Changes from baseline to endpoint were calculated from a three-day patient urinary diary and included a reduction in incontinence episodes and urinary frequency, and an increase in void volume. Additionally, 216 patients participated in a 14-week, open label, safety-extension study for a total of 26 weeks. During the double-blind portion of the trial, highly statistically significant improvements relative to placebo were seen on all of these endpoints.

Secondary endpoints also included a patient assessment of incontinence-specific, quality-of-life measures using multiple validated instruments including the Incontinence Impact Questionnaire (IIQ) and the King's Health Questionnaire, which indicated a significant positive effect of OTG treatment on quality-of-life total and subscale scores at endpoint in comparison with placebo.

OTG was well tolerated in the study. No serious adverse events related to the treatment were reported. Dry mouth (6.9%) and application site pruritis (2.1%) were the only treatment-related side effects reported at levels greater than 2%. Treatment-related adverse events that resulted in study discontinuation during the double-blind period were low (1.8%) and the similar for both the treatment and placebo groups.

Phase 1 studies have demonstrated that the steady-state plasma levels of oxybutynin show little fluctuation during the 24-hour dosin
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