Date: 2015-10-15
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Urogynecologic Society Meeting
Company: Allergan (Ireland)
Product: Botox® (onabotulinumtoxinA)
Action
mechanism: protein.
Disease: 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
Therapeutic area:
Country:
Trial details:
Latest
news: * On October 15, 2015, Allergan announced that results from an extension study of two phase 3 trials showed that long-term 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. Final results were presented in a podium session at the American Urogynecologic Society Meeting. Findings were based on a multicenter, 3.5-year extension study assessing the long-term safety and efficacy of onabotulinumtoxinA treatment in 749 female patients with OAB. Patients who completed either of two 24-week, phase 3 trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100 units) treatments. Of the 749 female patients enrolled, more than half (53%) completed the study. Discontinuations due to adverse events or lack of efficacy were low (4.8/5.3%); other reasons were not treatment-related.
Data were analyzed for the overall population of patients and within discrete subgroups of patients who received exactly 1, 2, 3, 4, 5, or 6 treatments of the 100U dose throughout the study. 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 >2.5 times the minimal important difference (+10 points). The overall median duration of effect was 8 months (38.4% >6 to <12 months). The most common adverse event was urinary tract infection, with no changes in safety profile over time.
