The Irish Medicines Board has given a positive opinion for Botox (botulinum toxin type A) for urinary incontinence management in adults with NDO (neurogenic detrusor overactivity) resulting from neurogenic bladder due to multiple sclerosis or stable sub-cervical spinal cord injury, Allergan Inc. has announced.
Allergan says this step is an important one toward securing national licences in 14 European nations which are involved int he Mutual Recognition Procedure. The positive opinion came after the Irish regulatory agency evaluated Allergan's successful global Phase III program.
Bladder dysfunction affects approximately 60% to 80% of people with multiple sclerosis (MS) and 75% to 80% of those with spinal cord injury (SCI), including urinary incontinence, a condition that can cause considerable distress.
Both MS and SCI patients often have bladders which contract during the filling stage, during which time they should be relaxed - this condition is known as neurogenic detrusor overactivity. This overactivity can result in uncontrolled urinary leaking, known as urinary incontinence.
By injecting Botox into the bladder muscle, the involuntary contractions subside and bladder activity increases, resulting in fewer urinary leaking incidents; in some cases the problem resolves completely.
Approximately 11,000 patients are diagnosed annually with SCI in Europe and about 656,000 individuals live with MS. A sizeable percentage of these people remain professionally and socially active, even though they face chronic mobility problems.
Urinary incontinence is often a socially isolating and disabling condition. Sufferers frequently experience low self esteem, loss of independence, embarrassment, and depression. MS and SCI patients with urinary incontinence are also more likely to develop skin irritations and ulcers, recurrent urinary tract infections and kidney failure. If overactivity of the detrusor muscle is not treated there is also a risk of serious health complications.
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