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Merz Pharmaceuticals Announces Approval of Post-stroke Upper Limb Spasticity Indication for Xeomin(R) in the EU
Date:11/18/2009

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In an intention-to-treat analysis among a total of 148 patients (NT 201=73; placebo=75), a larger proportion of NT 201 patients (mean 63.9%) were rated as responsive in each of five treatment muscle groups at week 4 as compared with patients receiving placebo (mean 35.72%). For the primary endpoint of wrist flexor treatment, the odds ratio (OR) of 3.97 favored NT 201 treatment significantly (95% confidence interval, 1.9-8.3; P <0.001). Significant ORs in favor of NT 201 ranging from 3.16 to 13.43 (P< 0.009) were observed for all other flexor muscle groups at week 4. Statistically significant results in favor of NT 201 were observed at all post-injection visits until week 12 in the principal therapeutic target (P less than or equal to 0.005), and in global assessment of efficacy by investigators, patients and caregivers (P < 0.001 for each). After 8 weeks of treatment, at least 50% of NT 201 patients were still responders in all muscle groups.

In Carer Burden Scale assessments (a measure of the impact on the physical care provider of hygiene and daily care tasks), significant advantages for NT201 were shown at week 4 in the tasks of putting the affected arm through a sleeve (p=0.021) and for cleaning the palm of the affected hand (p=0.028).

Adverse events, documented for 21 patients (28.8%) in the NT 201 group and in 20 patients (26.7%) in the placebo group were mostly mild in intensity. The majority (71%) of adverse events, including diarrhea, headache, hyperglycemia, contusion and hypercholesterolemia, resolved by the final visit.

About Post-stroke Spasticity

According to the National Stroke Association, 58 percent of stroke survivors experience post-stroke spasticity and only 51 percent of those are receiving treatment for that condition. Spasticity has been defined as a motor disorder characterized by a velocity-dependent increase in muscle tone with exaggerated tendon jerks, resultin
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SOURCE Merz Pharmaceuticals
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