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Subject: Xeomin for Focal Dystonia and Spasticity (MDS 2008) Date: 7/2/2008 Xeomin, a formulation of botulinum toxin type A (BoNT-A) without complexing proteins, is effective for focal dystonia and spasticity, according to two new trials. Other studies indicate it has the same unit potency as Botox, and can be stored at room temperature. The studies were funded by the manufacturer, Merz Pharmaceuticals.Focal Dystonia Analysis was conducted on pooled data from two randomized, multi-center trials comparing treatment with an equal number of units of Xeomin or Botox in patients with blepharospasm (n=300) or cervical dystonia (n=463). Global assessment of efficacy was rated as good or very good for both treatments by approximately 70% of investigators and 74% of patients. Duration of effect, 110-111 days, was the same for the two drugs. E-MOVE’s report on one of these studies is archived at http://www.mdvu.org/emove/article.asp?ID=832 Spasticity One hundred forty-eight patients with wrist and finger spasticity due to stroke were randomized to Xeomin or placebo. Some patients had previously been treated with other formulations of BoNT. The primary outcome variable was the percent responders at 4 weeks, defined as patients with at least a 1-point improvement in Ashworth score compared to baseline. For patients receiving either wrist flexor or finger flexor injections, response rate was 68% in the Xeomin-treated group, versus 37% in the placebo-treated group. Active treatment was also favored on the Disability Assessment Scale, which measures change in a patient-defined functional area. Potency The unit potencies of Xeomin and Botox were compared in blinded LD50 assays. Mean potency of 100 U from 5 batches of each drug were 101.7 for Botox, and 103.0 for Xeomin. Stability Forty-eight months at room temperature led to no loss of Xeomin potency compared to equivalently long refrigeration. Similar stability was observed for at least 18 months at 30 degrees Celsius, and for at least 6 months at 40 degrees Celsius. “The complexing proteins in pharmaceutical preparations of botulinum neurotoxin A are neither required for stability nor for the therapeutic affect,” the authors conclude. Efficacy of NT 201 (Xeomin) in focal dystonia W. Jost, S. Grafe, C. Georg 234;S80 Efficacy and safety of NT 201 (Xeomin) in the upper limb post-stroke spasticity in a double-blind, placebo-controlled, randomized, multi-center trial P. Kanovsky, I. Sassin, G. Comes, S. Grafe, NT 201 Study Group 1156; S377 Equivalent potency of Xeomin and Botox D. Dressler, G.J. Mander, K. Fink 49; S20 Xeomin is stable without refrigeration and is not affected by short-term temperature stress S. Grein, G.J. Mander, H.V. Taylor 61; S24 E-MOVE Editor: Richard Robinson, NASW, WE MOVE
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