Allergan's Botox is now licensed in the UK for patients who have continence issues because of multiple sclerosis or a spinal injury.
Specifically, the Medicines and Healthcare products Regulatory Agency has given Botox (botulinum toxin type A) the green light for managing urinary incontinence caused by neurogenic detrusor overactivity (NDO) due to subcervical spinal cord injury (SCI; traumatic or non-traumatic) or multiple sclerosis (MS), but only if treatment with anticholinergics isn't working.
Around 140,000 people in the UK are living with MS and SCI, of which between 75%-80% and 60%-80%, respectively, will suffer some degree of bladder dysfunction, including urinary leakage, caused by involuntary contractions of the bladder.
But despite existing treatment there remains an unmet need for people with the condition, as less than 30% of those taking an oral medication manage to do so for longer than 12 months, Allergan notes.
To date, the only other option for patients failing on oral medications has been surgery, but now they will have access to a new treatment option.
According to the firm, injecting Botox into the bladder muscle can reduce involuntary contractions and boost bladder capacity. This reduces the number of urinary leakage episodes and, in some patients, may even stop leakage altogether, it said.
The drug's license in this setting is based on two pivotal Phase III trials involving almost 700 patients with either SCI or MS who were not managed with at least one anticholinergic therapy.
Findings showed that 76% of patients treated with Botox had a statistically significant reduction in urinary wetting episodes (50% reduction or more) by week six compared to placebo.
Also, nearly 40% of patients treated with Botox were completely dry during week six compared to just 9% of patients in the control arm.
And further demonstrating its potential benefits, Botox-treated patients experienced statistically significant improvements in quality of life, including less avoidance behaviour, less psychosocial impact and less embarrassment compared to those on placebo, Allergan said.
Professor Christopher Chapple, Urology Department, Royal Hallamshire Hospital, Sheffield NHS Trust and a key investigator in the neurogenic detrusor overactivity registration trials, has welcomed the new license, noting that "being able to better control and manage bladder function can be life-changing for patients".
And Ed Holloway, Head of Care & Services Research at the MS Society, which funded one of the earliest trials of Botox in bladder control, has also expressed delight at the new approval.
“Continence issues are extremely common in people with MS and this treatment could greatly improve the quality of life for thousands of people in the UK,” he said.
Botox already has several licensed uses in the UK, including prevention of headaches in adults with chronic migraine, excessive sweating of the armpits, and the treatment of post stroke spasticity of the hand and wrist.