Botulinum toxin type A has been approved by The Irish Medicines Board to treat urinary incontinence management in adults with neurogenic detrusor overactivity (NDO).
The condition results from neurogenic bladder due to multiple sclerosis or stable sub-cervical spinal cord injury, Allergan Inc. has announced, reports Medical News Today.
Allergan says this step is an important one toward securing national licences in 14 European nations which are involved in the 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.
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, Medical News Today reports.
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 is resolved 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 and kidney failure, reports Medical News Today.
If overactivity of the detrusor muscle is left untreated, there is also a risk of serious health complications.
Douglas Ingram, President of Allergan in Europe, Africa and the Middle East, said they were “pleased” about the board’s positive opinion.
“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,” he added, Medical News Today reports.
