UK regulators have issued a green light for the use of Botox (botulinum type A) to treat ankle disability in patients who have suffered a stroke.
The seal of approval from the Medicines and Healthcare products Regulatory Agency's (MHRA) paves the way for patients to access a new treatment option shown to significantly improve muscle tone in stroke survivors with lower limb spasticity in clinical trials.
Welcoming "one of the most important advances the post stroke spasticity community has seen for years," Professor Anthony Ward of the North Staffordshire Rehabilitation Centre said "by allowing the ankle to function more normally, this can bring important mobility and physical benefits to patients, even those who have been suffering from this condition for many years".
Botox is now the first and only neuromodulator to be approved specifically for the treatment of both upper and lower limb spasticity in adults who have had a stroke, notes manufacturer Allergan.
The safety and efficacy of Botox has assessed in around 65 randomised, placebo-controlled clinical trials involving 10,000 patients, with more than 2,500 articles in scientific and medical journals, which makes Allergan’s neurotoxin one of the most widely researched toxin in the world, the firm claims.
The NHS list price for Botox 100 units is £138.20 excluding VAT, and usually treatment for lower limb spasticity is 300 units, injected across a number of different muscles. Given that there are very limited pharmacotherapy options available a comparison of cost of treatments is difficult, a spokesperson for Allergan told PharmaTimes World News.