Xeomin Approved for Adult Upper Limb Spasticity

Xeomin Approved for Adult Upper Limb Spasticity
Xeomin Approved for Adult Upper Limb Spasticity

Merz North America announced that Xeomin (incobotulinumtoxinA) has been approved by the Food and Drug Administration (FDA) for the treatment of upper limb spasticity in adults. 

Xeomin was studied in multiple Phase 3 studies in over 400 patients with upper limb spasticity. Its approval was based on data from a randomized, multi-center, placebo-controlled trial that showed significant improvements in 2 co-primary outcome endpoints: muscle tone and the Investigator's Global Impression of Change in the Primary Target Clinical Pattern at Week 4. A key secondary outcome measure was met where study patients with an improvement ≥1 on the Ashworth Scale at Week 4 were categorized as responders (P<0.001). Both outcomes showed statistical significance (P<0.001 and P=0.003, respectively). Its safety profile was similar to that seen for other Xeomin indications.

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Xeomin was initially approved by the FDA in August 2010 for the treatment of adults with cervical dystonia and blepharospasm. It works by blocking cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. 

It is available as 50 Units, 100 Units, and 200 Units strengths in single vial packs.

For more information call (888) 4-XEOMIN or visit Xeomin.com.

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