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–All primary and secondary endpoints were met for both Phase 3 studies (M21-500 and M21-508).–Results support BoNT/E as a novel botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and short duration of effect within 2-3 weeks.–If approved, BoNT/E will be the first neurotoxin of its kind available to patients.
IRVINE, Calif., Oct. 24, 2023 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced positive topline results from two pivotal Phase 3 clinical studies evaluating trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines (M21-500 and M21-508). The Phase 3 multicenter, randomized, double-blind, placebo-controlled studies evaluated the safety and efficacy of BoNT/E versus placebo in a total of 947 adult subjects with moderate to severe glabellar lines located between the eyebrows in the United States, Canada, and Europe. Subjects were either toxin-naïve or previously treated with neurotoxins and were evaluated over 12 weeks with up to two treatments of BoNT/E.
"BoNT/E is a first-in-class, short-acting neurotoxin in development, and these results demonstrate its potential to bring true innovation to the aesthetics industry," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "We are very pleased by these results, which provide strong evidence in support of BoNT/E's clinical profile and highlight significant progress within our next-generation toxin pipeline program."
The primary endpoints of both pivotal Phase 3 studies demonstrated statistical significance for improvement with BoNT/E versus placebo (p
