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.
Douglas Ingram, President of Allergan in Europe, Africa and the Middle East, said:
“We are pleased that BOTOX® has received a positive opinion following the Mutual Recognition Procedure for the treatment of urinary incontinence in people living with multiple sclerosis or spinal cord injury. For many people with spinal cord injury or multiple sclerosis, gaining effective control over their bladder and staying dry can be a significant step towards improving daily functioning and overall quality of life.
Our task now is to work closely with the national health authorities to secure the relevant national licences so that we can bring this valuable treatment option to patients, as quickly as possible.”
DIGNITY was a Phase III trial, according to Allergan “The largest clinical trial programme in neurogenic detrusor overactivity” which tested the efficacy and safety of Botox as a treatment for urinary incontinence due to neurogenic detrusor overactivity.
It consisted of two pivotal trials, which included 700 participants with either MS or SCI who had not responded properly to at least one anticholinergic treatment. Participants had to be willing to perform CIC (clean intermittent catheterization) to remove urine, when required.
Participants were randomly selected to receive either a placebo, 200 Units of Botox, or 300 Units of Botox – in all cases administered as one injection into the detrusor muscle using a rigid flexible cytoscope.
The study demonstrated that treatment was effective within a couple of weeks and lasted between eight to ten months.
Those receiving the Botox had considerably fewer urinary leakage incidents compared to those on the placebo.
Written by Christian Nordqvist