Allergan Aesthetics Announces Positive Topline Results from Two Pivotal Phase 3 Studies of TrenibotulinumtoxinE (BoNT/E) for the Treatment of Glabellar Lines
–All primary and secondary endpoints were met for both Phase 3 studies (M21-500 and M21-508).
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<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.
Treatment-emergent adverse events for BoNT/E were similar to placebo, both as a single treatment and up to two consecutive treatments.
"New patients considering facial aesthetic treatments may prefer a shorter-acting toxin with quick onset for their first treatment," said Cheryl Burgess, MD, FAAD, lead clinical investigator for one of the Phase 3 studies. "Treatment with a product differentiated by a rapid onset of effect and short duration of action could offer these patients a different option compared to currently available neurotoxins, and I see the potential for BoNT/E to help grow the toxin experience for the new patient population in my practice."
Additional study results will be submitted for presentation at future medical meetings. A Phase 3 open-label safety study is ongoing, with results expected later this year.
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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