Allergan Inc, Irvine, Calif, recently announced that the FDA has approved Botox (onabotulinumtoxinA) for injection for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition—eg, spinal cord injury (SCI) or 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. The current standard of care includes oral medications that are taken regularly, known as anticholinergics. However, it is estimated that 71% of people stop taking at least one oral medication within 12 months. If oral medications fail, then surgery may be considered (such as 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 6 (19.9 and 19.6 episodes/week versus 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 to 48 weeks for the 200U Botox group versus 13 to 18 weeks for the placebo group).