Allergan has announce that BOTOX(R) (botulinum toxin type A)
has received a positive opinion from the Irish Medicines Board for the
management of urinary incontinence in adults with neurogenic detrusor
overactivity (NDO) resulting from neurogenic bladder due to stable sub-cervical
spinal cord injury, or multiple sclerosis. This is an important step towards
securing national licences in the 14 European countries involved in the Mutual
Recognition Procedure and marks a key milestone in bringing this innovative
treatment to patients suffering from urinary incontinence due to neurogenic
detrusor overactivity. The positive opinion is specific for BOTOX(R) and is
based on Allergan's successful global phase III program.
Between 60-80% of people with multiple sclerosis (MS)2,3 and
75-80% of people with spinal cord injury (SCI) will suffer from some degree of bladder
dysfunction including urinary incontinence which can be distressing. Urinary
incontinence in patients with MS or SCI is frequently caused by a condition
called neurogenic detrusor overactivity (NDO), which results in involuntary
contractions of the bladder during the filling stage when the bladder should be
relaxed.
This overactivity can lead to urinary incontinence
(uncontrolled urinary leaking). Targeted injections of BOTOX(R) into the
bladder muscle have been shown to reduce the involuntary contractions and increase
bladder capacity. In turn, this reduces the number of urinary leaking
episodes and may even stop leaking altogether in some patients.
In Europe, approximately
656,000people live with MS7 and, on average, nearly 11,000 people are diagnosed
with SCI per year. Many of these people face long-term mobility issues, yet
remain professionally and socially active. Urinary incontinence can be a
disabling and socially isolating condition. It is also associated with
significant quality of life and emotional well-being implications such as
embarrassment, low self esteem, depression and loss of independence. Other
health implications of urinary incontinence in people living with MS or spinal
cord injury include skin irritation and ulcers, kidney failure and
recurrent urinary tract infections, which may lead to serious health
consequences, if the overactivity of the detrusor muscle is not treated.
"We are pleased that BOTOX(R) 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," said Douglas Ingram, President of Allergan in Europe, Africa and
the Middle East. "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."