Dysport Gains FDA Approval for Upper Limb Spasticity
Ipsen announced that the Food and Drug Administration (FDA) has approved Dysport (abobotulinumtoxinA) injection for the treatment of upper limb spasticity in adults. Dysport can be used to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors.
Dysport contains an isolated and purified form of botulinum toxin type A. Dysport is currently approved for the treatment of adults with cervical dystonia, and adults with moderate to severe glabellar lines.
The FDA approval was based on clinical trials that evaluated over 600 patients. The Phase 3 international, multi-center, double-blind, randomized, placebo-controlled study (n=238) compared the efficacy of Dysport vs. placebo in hemiparetic patients following stroke or brain trauma. The co-primary endpoints of the study were the improvement of muscle tone in the treated upper limb measured by the Modified Ashworth Scale (MAS) vs. placebo and the clinical benefit as assessed by the Physician Global Assessment (PGA) vs. placebo at Week 4.
Study data showed that treatment with Dysport led to statistically significant improvement in nn muscle tone and a significantly higher physician-rated clinical benefit vs. placebo at Week 4 (P≤0.05). Both doses of Dysport (500U and 1000U) significantly reduced muscle tone in all primary target muscle groups at Week 4.
For more information call (888) 525-2423 or visit Dysport.com.