Allergan Inc. announced that Botox has been approved by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of ankle disability due to lower limb spasticity associated with stroke in adults. This is the twelfth indication for Botox in the United Kingdom and marks a key milestone in bringing this treatment to stroke survivors who are suffering from lower limb spasticity. Spasticity is one of the most common consequences of stroke and may potentially lead to a significant loss of independence, affecting both the physical and emotional well-being of patients. This new approval offers healthcare professionals an important treatment option and provides a real advance for patients suffering from disabling lower limb spasticity.
"This is one of the most important advances the post stroke spasticity community has seen for years and will hopefully bring additional recognition to this complex and disabling condition," said Professor Anthony Ward of the North Staffordshire Rehabilitation Centre in the UK. "Studies show that Botox treatment can significantly improve the muscle tone in stroke survivors with lower limb spasticity. 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."
Stroke is a major public health issue in the UK with about 152,000 new cases each year. However, there are more than 1 million stroke survivors currently living in the UK who may be faced with a large range of challenges due to changes to the way their bodies function as a result of the stroke. Disability is common in stroke survivors, with 36% reporting moderate to very severe disabilities, often leading to a loss of independence. People who have had a stroke may have trouble with many "activities of daily living" (ADLs), including basic tasks such as walking, bathing, dressing, eating, and using the toilet. Studies showed that the prevalence of spasticity does not differ between the upper and the lower limbs, affecting the wrist (66%) and the ankle (66%) of those patients. Moreover, 63% of stroke survivors with spasticity experience this in both the upper and lower limbs. Treatment of lower limb spasticity associated with stroke requires a multidisciplinary approach and usually includes physical therapy, pharmacological treatments, and, in some cases, surgery.
Joe Korner, director of External Affairs at the Stroke Association, said: "There can be significant advantages in using Botox to treat people whose movement and walking ability have been affected by stroke. Up to 30% of stroke survivors are living with muscle stiffness, known as post-stroke spasticity, which means they have abnormal tightness in some of their muscles. This painful condition can cause a devastating loss of independence. Whilst this treatment might not be suitable for every stroke patient, we encourage stroke survivors living with spasticity in their arms or legs to talk with their GP about management options that might be right for them."
This new indication is based on an multi-center, randomized, double-blind, placebo-controlled study, assessing its efficacy in patients with post-stroke lower limb spasticity affecting the ankle. A total of 120 patients were randomized to a single treatment of Allergan's Botulinum toxin type A (300 units) or placebo. Patients who were enrolled in this study had had their stroke on average approximately six years earlier.
Date: February 4, 2014