FDA approves onabotulinumtoxinA for certain types of incontinence

September 8, 2011

The FDA recently approved onabotulinumtoxinA (Botox) injection for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

The FDA recently approved onabotulinumtoxinA (Botox) injection for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

In manufacturer Allergan Inc.’s two phase III clinical trials, injecting onabotulinumtoxinA, 200 U, directly into the bladder muscle reduced urinary incontinence episodes by approximately 20 episodes per week at week 6 (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 onabotulinumtoxinA when the clinical effect of their previous treatment wore off, which in the trials was up to 10 months (42-48 weeks for the onabotulinumtoxinA, 200 U, group vs. 13-18 weeks for the placebo group).

In a press release, Allergan called onabotulinumtoxinA "a new long-lasting treatment option to reduce urinary incontinence episodes and address a particularly burdensome issue."

"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," said Victor Nitti, MD, of the New York University Langone Medical Center, who was involved in the onabotulinumtoxinA phase III clinical trial program.

The most frequently reported adverse reactions within 12 weeks of receiving injections for detrusor overactivity associated with a neurologic condition included urinary tract infection (24%), urinary retention (17%), hematuria (4%), fatigue (4%), and insomnia (2%).