FDA approves Dysport for treatment of lower limb spasticity

June 28, 2017
The U.S. Food and Drug Administration has expanded the approved use of Dysport® (abobotulinumtoxinA) for the treatment of spasticity in adults.
 
In a Phase III study, adult patients treated with Dysport following a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint, measured by the mean change from baseline on the Modified Ashworth Scale at week four. The duration of response for the majority of patients within the study was between 12-16 weeks. In this study, some patients experienced a longer duration of response.
 
Dysport comes with a warning that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. Dysport is not for patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow’s milk protein.
 
Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness in one or more muscles, which might interfere with movement. Spasticity is usually caused by damage to nerve pathways in the brain or spinal cord that control muscle movement, and two in three patients with MS will develop lower limb spasticity.
 
Lower limb spasticity commonly involves spasticity in calf muscles, which, during walking, work to raise the heel from the ground. Symptoms of spasticity may include increased muscle tone, rapid muscle contractions, exaggerated deep tendon reflexes, and/or muscle spasms. The degree of spasticity can vary from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.

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