FDA approves Allergan's BOTOX to treat specific form of urinary incontinence

Aug 25 2011

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."

People living with MS develop lesions on the spinal cord, while people who sustain a spinal cord injury have irreversible nerve damage, resulting in the inability of the spinal cord and bladder to communicate effectively. As a result, the bladder muscle involuntarily contracts, increasing the pressure in the bladder and decreasing the volume of urine the bladder can hold, which causes the individual to leak urine frequently and unexpectedly. BOTOX® neurotoxin temporarily prevents muscle contractions by blocking the transmission of nerve impulses to the muscle, in this case, the bladder muscle, by selectively preventing the release of the neurotransmitter acetylcholine (ACh) at the neuromuscular junction.

"Urinary incontinence or leakage is often considered a taboo subject. Studies have shown that many patients are undiagnosed and undertreated because they are too embarrassed to talk to their doctor about their symptoms. This is particularly true for patients with neurological conditions that are associated with urinary incontinence due to detrusor overactivity. Many of these patients don't get referred to a urologist who can diagnose and manage their bladder condition," said Dr. Victor Nitti, Vice-Chairman, Department of Urology, NYU Langone Medical Center, who was involved in the BOTOX® Phase III clinical trial program. "When not adequately managed, urinary incontinence due to detrusor overactivity in patients living with MS or SCI can lead to skin irritation, ulcers, pressure increases in the bladder that can cause kidney failure, as well as recurrent urinary tract infections."

Source: Allergan, Inc.