The ‘big pharma’ company Allergan has been granted a Medicines and Healthcare Products Regulatory Agency (MHRA) licence for the use of Botox as a treatment for urinary incontinence among certain patient groups in the U.K.
The drug has been approved for use in patients with neurogenic detrusor overactivity due to traumatic or non-traumatic subcervical spinal cord injury or multiple sclerosis who are not adequately managed with anticholinergics.
This authorisation is specific to the botulinum toxin type-A product and is based on positive data from the phase III study programme Dignity, which involved two pivotal trials among nearly 700 patients.
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