Phase III extension studies show advantages of Botox (onabotulinumtoxinA) in urinary incontinence- Allergan

Allergan has announced that results from an extension study of two phase III trials showed that long-term Botox (onabotulinumtoxinA) treatment consistently decreased urinary incontinence in female patients with overactive bladder (OAB) symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication. Findings were based on a multicentre, 3.5-year extension study assessing the long-term safety and efficacy of onabotulinumtoxinA treatment in 749 female patients with OAB.

Mean reductions from baseline in urinary incontinence episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups of female patients who received 1 to 6 treatments. A consistently high proportion of patients reported improvement or great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments (69.6–100%). Incontinence Quality of Life scores were consistently more than 2.5 times the minimal important difference (+10 points). The overall median duration of effect was 8 months (38.4% between 6 and 12 months). The most common adverse event was urinary tract infection, with no changes in safety profile over time. Final results were presented in a podium session at the American Urogynecologic Society Meeting.