NT 201 (Merz) is Clinically Equivalent to BOTOX

Subject: NT 201 (Merz) is Clinically Equivalent to BOTOX

Date: 9/1/2005

Two studies show that a new BTX-A preparation free of complexing proteins has equivalent short-term clinical efficacy to BOTOX.

1. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia
R Benecke, WH Jost, P Kanovsky, E Ruzicka, G Comes, S Grafe
Neurology 2005;64:1949-1951

Four hundred twenty cervical dystonia patients at 11 European centers were randomized to receive BOTOX or NT201, a freeze-dried preparation of BTX-A free of complexing proteins from Merz Pharmaceuticals. Median baseline TWSTRS severity score was 18 (out of 35), which improved in both groups to 11 by day 28, and then worsened in a similar fashion in both groups over time. No significant differences between groups were found in final TWSTRS severity score, pain measured by either TWSTR subscore or visual analog scale, or adverse events.

“We thus conclude that the complexing proteins contained in currently marketed BTX-A preparations are dispensable for clinical efficacy,” the authors state.

2. Efficacy and tolerability of a botulinum toxin type A free of complexing proteins (NT201) compared with commercially available botulinum toxin type A (BOTOX) in healthy volunteers
WH Jost, A Kohl, S Brinkmann, G Comes
J Neural Transm 2005;112:905-913

Fourteen healthy volunteers received 4 units of BOTOX and 4 units of NT201 into the extensor digitorum brevis muscle of either foot, randomized by side. In both groups, reduction of compound muscle action potential was maximal from day 7 to 14, and declined to 40% maximum by day 90, with no significant differences between groups for magnitude or duration of CMAP reduction.