FDA Approves Xeomin for Upper Limb Spasticity

December 23, 2015

Xeomin (incobotulinumtoxinA, Merz North America) has received FDA approval for the treatment of upper-limb spasticity (ULS) –– the abnormal head position and neck pain that occurs with cervical dystonia in adults. In clinical studies, treatment with Xeomin in adults with ULS resulted in statistically and clinically significant improvements in muscle tone.

Xeomin was first approved in August 2010 for the treatment of adults with cervical dystonia and blepharospasm.

The safety and efficacy of Xeomin were evaluated in phase III clinical studies involving more than 400 adults with ULS. The approval of Xeomin for the treatment of ULS in adults was based on results from a randomized, placebo-controlled trial in which subjects experienced significant improvements in two co-primary outcome measures: muscle tone (Ashworth Scale score) and the Investigator’s Global Impression of Change of the Primary Target Clinical Pattern (PTCP) at week 4. Both parameters showed statistical significance (P < 0.001 and P = 0.003, respectively). The trial also met a key secondary outcome measure, in which subjects with an improvement of 1 or greater on the Ashworth Scale at week 4 were classified as responders (P < 0.001).

Treatment-related adverse events were reported in 3.8% and 1.9% of subjects treated with Xeomin or placebo, respectively. The most common adverse events observed with Xeomin included seizures (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).

Xeomin is injected into muscles. It is used to treat increased muscle stiffness in the arms of adults with ULS and blepharospasm in adults who have been treated with onabotulinumtoxinA (Botox, Allergan, Inc.).

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