Abstract
MT10107 is botulinum neurotoxin type A derived drug which utilizes the 150 kDa portion without complexing proteins and human serum albumin contents. To evaluate the efficacy and the safety of MT10107, it was compared with onabotulinumtoxinA in this double-blind, randomized controlled trial. Twenty-five healthy males received a randomly selected dose of MT10107 into the extensor digitorum brevis (EDB) muscle of one foot, and an equivalent dose of onabotulinumtoxinA (BOTOX) was injected into the contralateral EDB muscle. While efficacy of the administered substance was determined by measuring paretic effects on the EDB, the local spread of toxin effects was evaluated by the paretic effects on the nearby abductor hallucis (AH) and abductor digiti quinti (ADQ) muscles. Paretic effects were defined as the percentage of reduction of the compound muscle action potential (CMAP) amplitudes, measured at 14, 30, 90 days after the injection, compared to the baseline value. Intergroup (MT10107 and onabotulinumtoxinA) differences were not significant in the percentage reduction of the amplitudes in the EDB muscles. In this study, there was no significant difference in efficacy and safety between the two test drugs. MT10107 may be effective and safe as much as onabotulinumtoxinA to produce the desired paretic effect.
Highlights
In past decades, botulinum neurotoxin type A (BoNT/A) has been used as treatment for neuromuscular disorders such as blepharospasm, strabismus, hemifacial spasm, and cervical dystonia
All the enrolled volunteers were healthy male subjects who were in their twenties 20 s and thirties 30 s except for one 50-year-old subject
Antibodies were not detected in any subject before or after the injection. Both the efficacy and the safety of MT10107 were assessed after injections into the extensor digitorum brevis (EDB) muscle of one foot and compared with onabotulinumtoxinA after the injection on the contralateral foot in healthy male adult volunteers
Summary
Botulinum neurotoxin type A (BoNT/A) has been used as treatment for neuromuscular disorders such as blepharospasm, strabismus, hemifacial spasm, and cervical dystonia. It has been applied in aesthetic facial rejuvenation including effacement of rhytides by inhibiting the contraction of facial expression muscles [1]. Among the preparations of BoNT/A on the market, incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals, Frankfurt am Main, Germany) is the only complexing protein-free BoNT/A [2]. IncobotulinumtoxinA has presented similar efficacy and safety, compared with the onabotulinumtoxinA (BOTOX, Allergan, CA, USA) which contains nontoxic proteins [2,3,4,5].
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