Proof of Concept, Feasibility, and Safety of Local Anticholinesterase Treatment for Neuromodulator-Induced Facial...

As yet, there is no functional focal reverser for the adverse effects of cosmetic botulinum toxin injections.

The authors report the first Phase 1 study in human subjects of local administration of an anticholinesterase for reversing muscle weakness, which may result from these neurotoxin-induced complications.

An anticholinesterase, or cholinesterase inhibitor, indicated for reversal of neuromuscular blockage in anesthesia, was injected into the same 5 injection sites as were used for the cosmetic onabotulinum toxinA, glabellar treatment.

In most patients treated with the reversal agent under investigation, there was a notable recovery of cosmetic blockade; no subject treated with placebo demonstrated a reversal response. Evidence of reversal became evident within the first 15 minutes after injection of the study drug, with no major or persistent adverse events.

Proof of concept, feasibility, and safety of local neuromodulator reversal are now shown; however, further studies are required to optimize dosage, distribution, and formulation.