Allergan Inc Announces Positive Top-Line Results From Phase III BOTOX Overactive Bladder Program

Allergan Inc announced that two Phase III clinical trials of BOTOX (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment. The full study results of the North American Phase III study are expected to be presented at an upcoming medical meeting. Based on the results of the two Phase III clinical trials, Allergan has submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX is currently approved in the United States and in several European countries for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.