Allergan Aesthetics Announces Positive Topline Results from Two Pivotal Phase 3 Studies of TrenibotulinumtoxinE (BoNT/E) for the Treatment of Glabellar Lines

Posted By Madilyn Moeller, Thursday, October 26, 2023

Allergan Aesthetics, an AbbVie company

Allergan Aesthetics, an AbbVie company, 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<0.0001) in glabellar line severity on the Facial Wrinkle Scale (FWS) from baseline at day 7 (based on both subject and investigator assessments). All tested secondary endpoints, including patient-reported outcomes on overall treatment satisfaction, demonstrated statistical significance, favoring improvement with BoNT/E versus placebo. The onset of efficacy (i.e., at least 2-grade FWS improvement from baseline) was demonstrated at 8 hours after drug administration (the earliest assessment time) and efficacy duration was observed for 2-3 weeks after drug administration.

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