Allergan plc today announced that results from an extension study of two phase 3 trials showed that long-term onabotulinumtoxin A 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.
Allargan says that the 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.
According to Allergan, 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.
“Results of this extensive 3.5-year study demonstrates consistent safety and efficacy of long-term onabotulinumtoxinA treatment in this population of female overactive bladder patients,” said Peter Sand, M.D., urogynecologist and clinical professor, North Shore University Health System, University of Chicago.
“These findings may help inform specialists treating patients with overactive bladder, that BOTOX is an effective and safe treatment option for patients not getting the relief from an anticholinergic.”