E-MOVE Research News
Subject: BTX-A current bulk toxin vs. original (AAN report)
Date: 4/30/1999
1. BOTOX® (botulinum toxin type A) purified neurotoxin complex prepared from the new bulk toxin retains the same preclinical efficacy as the original but with reduced immunogenicity
R Aoki, G Merlino, A Spanoyannis, L Wheeler
Neurology 1999;52(Suppl 2):A521-522
(The abstract presented at the AAN differs somewhat from the published abstract; the data below reflect that from the AAN poster presentation)
The current lot of BOTOX is as potent as the original, but less immunogenic, according to this study.
Potency was measured in mice by injection into the right gastrocnemius of 0.43-40 Units/kg current or original toxin, or placebo. Dose response curves, as measured by Digit Abduction Scores, were virtually identical, as were ED50 values (3.4 +/- 0.2 U/kg for the original, 3.5 +/- 0.3 U/kg for the current).
Antigenicity was determined in rabbits by 8 monthly injections of toxin with concurrent immunoblotting, followed by serum analysis via the mouse protection assay at the end of the 8 months. Eight of nine rabbits injected with original toxin developed neutralizing antibodies, while only 1 of 9 injected with current toxin did.
This study was supported by Allergan, Inc.
2. Cervical dystonia: A retrospective study on safety and efficacy of BOTOX® lots 79-11 and 2024
R Benabou, MF Brin, JT Doucette
Neurology 1999;52(Suppl 2):A117-118
Current (2024) and original (79-11) BOTOX have similar efficacy and adverse event profiles, according to this retrospective study.
Forty-seven patients treated with original toxin and 32 patients treated with current toxin completed questionnaires regarding onset, duration, and peak effect of benefit, and adverse events. Results indicated no significant differences between the groups for any of the measures examined.
