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Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients
Date:4/28/2009

s. AEs were reported in 70.3% subjects in the NT-201 group and 61.8% subjects in the placebo group. The most commonly reported AEs were eyelid ptosis (18.9 vs. 8.8%), dry eye (16.2 vs. 11.8%), and dry mouth (16.2 vs. 2.9%).

Clinical efficacy in focal dystonia and overall tolerability of NT-201 (botulinum neurotoxin free from complexing proteins) Presented by Susanne Grafe of Merz Pharmaceuticals GmbH, Frankfurt, Germany.

Methods

This study assessed the overall clinical efficacy and tolerability of NT-201 (botulinum neurotoxin free from complexing proteins). Efficacy analyses in focal dystonia were performed on pooled data from 2 pivotal clinical trials in blepharospasm and cervical dystonia (343 NT-201 patients; 340 BoNT patients). For the safety analyses, 6 clinical trials (blepharospasm, cervical dystonia and upper limb spasticity) were included (n=539 NT-201, n=442 BoNT and n=75 placebo subjects, respectively). 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 (BoNT) have been used with a dose ratio of 1:1. The results demonstrate equivalent efficacy between the two products. Onset, waning, and duration of effect were comparable. These findings have been confirmed by the Global Impression of Physician: 70.6% of BoNT patients and in 71.8% of the NT-201 patients were rated as "good" or "very good." A total of 26.7% of patients in the NT-201 group, 26.0% in the BoNT group and 22.7% in the placebo group reported an adverse event. There were no clinically relevant differences between the two treatment groups. All adverse reactions were either already known and/or were considered unlikely to be related to NT-201 by the physician. The analysis of the 67,000 patients treated post-launch dem
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