Allergan is pleased to announce that BOTOX (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? and is based on Allergan’s successful global phase III programme.
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 distressing2-4. 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? into the bladder muscle have been shown to reduce the involuntary contractions and increase bladder capacity5,6. In turn, this reduces the number of urinary leaking episodes and may even stop leaking altogether in some patients1.
In Europe, approximately 656,000 people live with MS7 and, on average, nearly 11,000 people are diagnosed with SCI per year8,9. Many of these people face long-term mobility issues, yet remain professionally and socially active. Urinary incontinence can be a disabling and socially isolating condition10. It is also associated with significant quality of life and emotional well-being implications such as embarrassment, low self esteem, depression and loss of independence10. Other health implications of urinary incontinence in people living with MS or spinal cord injury include skin irritation and ulcers, kidney failure4,11 and recurrent urinary tract infections, which may lead to serious health consequences, if the overactivity of the detrusor muscle is not treated.
Allergan, Inc. is a multi-specialty health care company focused on discovering, developing and commercializing innovative pharmaceuticals, biologics, medical devices and over-the-counter consumer products that enable people to live life to its greatest potential – to see more clearly, move more freely, express themselves more fully.
Source: Allergan, USA