Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for injection 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. Urinary incontinence (bladder leakage) due to detrusor (bladder muscle) overactivity in patients living with MS or SCI is a chronic condition affecting approximately 340,000 people in the United States. Current standard of care includes oral medications that are taken regularly, known as anticholinergics; however, it is estimated that 71 percent of people stop taking at least one oral medication within 12 months. If oral medications fail, then surgery may be considered (e.g. implanting a neuromodulation device or bladder augmentation surgery).
BOTOX® neurotoxin was studied in people living with MS and SCI with urinary incontinence due to detrusor overactivity who had an inadequate response to or who were intolerant of an anticholinergic medication. In Allergan's two Phase III clinical trials, injecting 200 units of BOTOX® directly into the bladder muscle reduced urinary incontinence episodes by approximately 20 episodes per week at week six (19.9 and 19.6 episodes/week vs. 10.6 and 10.8 for the placebo group)). Patients in the clinical trials were considered for retreatment with BOTOX® when the clinical effect of their previous treatment wore off, which in the trials was up to 10 months (42-48 weeks for the 200U BOTOX® group vs. 13-18 weeks for the placebo group).
"Urinary incontinence due to detrusor overactivity in patients with a neurologic condition is a serious medical problem, and for people who do not respond to or cannot tolerate the side effects of an oral anticholinergic medication, BOTOX® is a new long-lasting treatment option to reduce urinary incontinence episodes and address a particularly burdensome issue," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. "We are proud to bring the seventh medical use of BOTOX® in the United States to market. BOTOX® is the first neurotoxin to undergo formal clinical evaluation and receive FDA approval for a urological indication. This approval of BOTOX® is an important milestone in Allergan's commitment to develop and make available novel treatment options for urologists and their patients."