Ipsen has announced that the Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in adults.
The sBLA submission was based on a Phase 3 study involving 250 adult patients with upper limb spasticity. The international, multi-center, double-blind, randomized, placebo-controlled trial compared the efficacy of Dysport vs. placebo in hemiparetic patients following stroke or brain trauma. The data showed that those treated with Dysport demonstrated a statistically significant improvement in muscle tone (P<0.0001), and a higher clinical benefit vs. placebo.
Dysport is a botulinum toxin type A that acts at the level of the neuromuscular junction in the targeted muscle and inhibits release of acetylcholine from peripheral cholinergic nerve endings.
For more information call (888) 525-2423 or visit Dysport.com.