Dysport (abobotulinumtoxinA), marketed by the pharmaceutical company Ipsen, has been approved by the U.S. Food and Drug Administration (FDA) to treat upper and lower limb spasticity in adults (a common symptom of multiple sclerosis) and is currently being studied as a treatment for overactive bladder in MS patients.
It is administered as an injection directly into the muscle.
How Dysport works
Patients with MS can experience urinary incontinence due to neurogenic detrusor overactivity (NDO) or an overactive bladder. Lesions in the nervous system caused by MS can affect the transmission of messages between the brain and the detrusor muscle of the bladder. This results in sudden contractions of the bladder muscles, leading to a sudden increase in bladder pressure and a decreased capacity to contain urine, which can lead to unexpected leakage.
Dysport is an injectable form of purified botulinum toxin A, a protein produced by the bacteria Clostriudium botulinum. The toxin blocks neuromuscular conduction between nerve and muscle cells leading to short-term, localized relaxation of the targeted muscle.
Dysport in clinical trials
Dysport has not yet been approved by the FDA to treat urinary incontinence in adults with NDO caused by spinal cord injury (SCI) or MS. Studies into the effect of generic botulinum toxin A on the bladder symptoms of MS patients have been carried out and published.
A Phase 2 randomized, double-blind, placebo-controlled trial (NCT01357980) for the treatment of NDO in MS has been completed. During the trial, 47 patients were randomly assigned to Dysport or placebo (with either 15 or 30 injection sites). The injections were carried out over a single day, and the patients were monitored for 84 days.
The study identified a significant difference in the average daily frequency of incontinence episodes between the Dysport- and placebo-treated groups who were given injections at 30 sites. A significant increase in the perceived bladder capacity was observed in patients injected with Dysport (with both 15 or 30 sites) compared to the placebo group. Patients reported an improved quality of life following Dysport injection compared to patients treated with the placebo.
Following these positive results, Ipsen has proceeded to Phase 3 trials to assess the safety and effectiveness of Dysport for the treatment of urinary incontinence in people with MS or SCI. The non-U.S. arm of the trial (NCT02660359), called CONTENT2, is currently recruiting participants at multiple locations worldwide.
The botulinum toxin may have several adverse effects. These may spread from the area of injection and produce symptoms such as swallowing, speaking, and breathing difficulties that could last for several weeks and which can be life-threatening.
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