FDA Expands Dysport Use for Lower Limb Spasticity in Adults
The FDA approval was based on data from a Phase 3, multi-center, prospective, double-blind, randomized, placebo-controlled study in 381 adults treated with Dysport 1000 Units, Dysport 1500 Units or placebo after a stroke or traumatic brain injury. The data showed improvement in muscle tone at the ankle joint, as assessed by the change from baseline in the Modified Ashworth Scale (MAS) at Week 4 (P<0.05).
Dysport 1500 Units injection was associated with a statistically significant improvement in muscle tone and spasticity at the ankle joint. The duration of response ranged between 12–16 weeks with some patients experiencing response up to approximately 20 weeks. The most common adverse reactions were falls, muscular weakness, and pain in extremity.
“Adult patients who have developed spasticity as a result of a stroke, multiple sclerosis, cerebral palsy, spinal cord injury, or traumatic brain injury now have another option when seeking treatment that helps reduce the effects of the increased muscle tone in their lower extremities,” said Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen.
Dysport is already indicated for the treatment of cervical dystonia and upper limb spasticity in adults as well as lower limb spasticity in children aged ≥2 years. It is supplied as a lyophilized powder containing a form of botulinumtoxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A. Dysport and all botulinum toxin products have a Boxed Warning which states 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.
For more information visit Dysport.com.