Abstract
The biological potency of botulinum toxin (BT) drugs is determined by a standardised LD50 assay. However, the potency labelling varies vary amongst different BT drugs. One reason for this may be differences in the LD50 assays applied. When five unexpired batches of onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) are compared in the Xeomin® batch release assay, the potency variability of both BT drugs fell within the range allowed by the European Pharmacopoiea. Statistical analyses failed to detect differences in the potency labelling of both products. Although the existence of a conversion ratio has been questioned recently, our experimental data are in line with previous clinical experience showing that Botox® and Xeomin® can be compared using a 1:1 conversion ratio. Identical potency labelling allows easy exchange of both BT drugs in a therapeutic setting, and direct comparison of efficacy, adverse effects and costs.
References
Benecke R, Jost WH, Kanovsky P, Ruzicka E, Comes G, Grafe S (2005) A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurology 64:1949–1951
Brin MF, Blitzer A (1993) Botulinum toxin: dangerous terminology errors. J R Soc Med. 86:493–494
Dressler D (2009) Routine use of Xeomin® in patients pre-treated with Botox®. Eur J Neurol 16(Suppl 2):2–5
Dressler D (2010) Comparing Botox® and Xeomin® for the treatment of axillar hyperhidrosis. J Neural Transm 117:317–319
Dressler D, Bigalke H (2009) Pharmacology of botulinum toxin drugs. In: Truong D, Dressler D, Hallett M (eds) Botulinum toxin therapy. Cambridge University Press, Cambridge, UK
European Pharmacopoeia 6.0 (2008a) Botulinum toxin type A for injection. pp 1327–1329
European Pharmacopoeia 6.0 (2008b) Statistical analysis of biological assays and tests. 5.3, pp 571–600
First ER, Pearce LB, Borodic GE (1994) Dose standardisation of botulinum toxin. Lancet 343:1035
Hambleton P, Pickett AM (1994) Potency equivalence of botulinum toxin preparations. J R Soc Med 87: 719
Hunt T, Clarke K (2009a) Potency evaluation of a formulated drug product containing 150-kd botulinum neurotoxin type A. Clin Neuropharmacol 32:28–31
Hunt T, Clarke K (2009b) Editorial response letter to Mander et al. Clin Neuropharmacol 32: 235
Mander G, Fink K, Vey M (2009) Experimental conditions substantially influence botulinum toxin potency testing. Clin Neuropharmacol 32:234
Marion MH, Sheehy M, Sangla S, Soulayrol S (1995) Dose standardisation of botulinum toxin. J Neurol Neurosurg Psychiat 59:102–103
Marsden CD (1993) Botulinum toxin: dangerous terminology errors. J R Soc Med 86:494
McLellan K, Gaines Das RE, Ekong TAN, Sesardic D (1996) Therapeutic botulinum type A toxin: factors affecting potency. Toxicon 34:975–985
Ranoux D, Gury C, Fondarai J, Mas JL, Zuber M (2002) Respective potencies of botox and dysport: a double blind, randomised, crossover study in cervical dystonia. J Neurol Neurosurg Psychiatry 72:459–462
Roggenkämper P, Jost WH, Bihari K, Comes G, Grafe S; for the NT 201 Blepharospasm Study Team (2006) Efficacy and safety of a new botulinum toxin type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm 113:303–312
Van den Bergh P, Lison D (1996) Dose standardisation of BTX. In: 3rd international dystonia symposium, 9–11 October, 1996, Miami, Florida. Affiliated National Dystonia Associations, Chicago, p 30
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Dressler, D., Mander, G. & Fink, K. Measuring the potency labelling of onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in an LD50 assay. J Neural Transm 119, 13–15 (2012). https://doi.org/10.1007/s00702-011-0719-1
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DOI: https://doi.org/10.1007/s00702-011-0719-1