Allergan announced results from an extension study of two Phase 3 trials on the long-term safety and efficacy of Botox (onabotulinumtoxinA) in female patients with overactive bladder (OAB) with symptoms of urge urinary incontinence. The findings were presented at the American Urogynecologic Society Meeting.
The multicenter, 3.5 year extension study was designed to assess the long-term safety and efficacy of Botox treatment in 749 patients with OAB who had completed either of two 24-week Phase 3 trials. Data were analyzed for the total population and for subgroups who received 1, 2, 3, 4, 5, or 6 treatments of the 100U dose throughout the study. The primary endpoints included reductions from baseline in urinary incontinence episodes per day.
Mean reductions from baseline in urinary incontinence episodes per day at Week 12 were consistent among the subgroups who received 1– 6 treatments. A consistently high proportion of patients reported improvement or great improvement on the Treatment Benefit Scale at Week 12 and Incontinence Quality of Life scores were consistently >2.5 times the minimal important difference (+10 points). The median duration of effect was 8 months overall.
Botox is indicated for prophylaxis of headaches in adults with chronic migraine (≥15days/month with headache lasting 4hrs/day or longer); severe primary axillary hyperhidrosis when topical agents are inadequate; treatment of upper limb spasticity in the flexor muscles of the elbow, wrist, and finger in patients ≥18yrs; cervical dystonia in patients ≥16yrs, to reduce severity of abnormal head position and neck pain; strabismus or blepharospasm related to dystonia in patients ≥12yrs; adults who have an inadequate response to or are intolerant of an anticholinergic drug: in overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency or urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis).
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