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Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting
Date:6/8/2009

n focal dystonia was analyzed on the pooled data from 2 pivotal clinical trials in blepharospasm and cervical dystonia (343 NT 201 patients; 340 BTXCo* patients) and 1 post-stroke spasticity trial (73 NT 201 patients and 75 placebo patients). For the safety analyses, 6 clinical trials (blepharospasm, cervical dystonia, and upper limb spasticity) have been included (n=539 NT 201, n=442 BTXCo and n=75 placebo subjects). For the post-launch evaluation spontaneously reported adverse events were analyzed.

Results

In the randomized, active-controlled, double-blind studies in focal dystonia NT 201 and one other Botulinum toxin (BTXCo) have been used with a dose ratio of 1:1. The results demonstrate equivalent efficacy between the NT 201 and BTXCo. Onset, waning, and duration of effect were comparable. These findings have been confirmed by the Physician´s Global Impression of Efficacy: 70.6% of BTXCo patients and 71.8% of the NT 201 patients were rated as "good" or "very good." Additionally, in the placebo-controlled spasticity trial 62% of the caregivers rated the efficacy as good or very good compared to placebo (33%). 26.7% of patients in the NT 201 group, 26.0% in the BTXCo group, and 22.7% in the placebo group reported an adverse event. There were no clinically relevant differences between the two active treatment groups in the focal dystonia trials and between NT 201 and placebo in the post-stroke spasticity trial concerning safety aspects. All adverse reactions were either already known and/or were considered by the physician unlikely to be related to NT 201. More than 67,000 patients have been treated so far and no new safety concerns have been reported.

Second Study - Title

NT201 (Xeomin(R); botulinum neurotoxin free from complexing proteins) is efficacious and well-tolerated in upper limb spasticity of various etiologies authored by Barnes, M., Schnitzler, A., Amaral e Silva, A., Aquilar, M., Lehner
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SOURCE Merz Pharmaceuticals
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