Positive results from Allergan's BOTOX Phase III trials on idiopathic overactive bladder

Allergan, Inc. (NYSE: AGN) today 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 summary data are being presented as part of Allergan's Research and Development Technology Review, which will be held today at 1 p.m. Eastern Time. 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.

"Allergan is committed to the research and clinical development of novel treatment options for urologists and their patients, and we look forward to potentially expanding the use of BOTOX^® as a treatment option following approval by the respective regulatory agencies," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development, Chief Scientific Officer. "We are pleased with the results of our idiopathic overactive bladder Phase III clinical trials, which demonstrated that BOTOX^® treatment provided benefit to these overactive bladder patients with symptoms of urinary incontinence who failed or were intolerant of other therapy."