
Allergan Aesthetics Reports Positive Phase 3 Trial Results for New Fast Acting Neurotoxin for Face Wrinkles
AbbVie’s aesthetics subsidiary, Allergan Aesthetics, has revealed new topline results from two pivotal Phase 3 clinical studies assessing the efficacy of trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines (the vertical lines between the eyebrows).
The Phase 3 clinical trials, conducted as multicenter, randomized, double-blind, placebo-controlled studies, involved 947 adult participants with moderate to severe glabellar lines located between their eyebrows. These trials were carried out across the United States, Canada, and Europe. The participants were either new to neurotoxin treatments or had prior experience with them. The study spanned over 12 weeks, allowing for up to two treatments with BoNT/E.
In these pivotal Phase 3 trials, the primary endpoints showcased statistically significant improvements in glabellar line severity when compared to the placebo, based on assessments from both subjects and investigators. The results were visible as early as day 7 and were supported by strong statistical significance (p<0.0001). Additionally, secondary endpoints, such as patient-reported outcomes on overall treatment satisfaction, favored BoNT/E over the placebo. The onset of efficacy, with at least a 2-grade improvement from baseline, was observable as quickly as 8 hours after administering the drug, and its effects remained effective for 2-3 weeks post-administration. Moreover, the safety profile of BoNT/E was found to be similar to that of a placebo, both as a single treatment and when administered consecutively up to two times.
Darin Messina, Senior Vice President of Aesthetics R&D at AbbVie, stated, “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. 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 company noted the presentation of additional study results at future medical meetings, while an ongoing Phase 3 open-label safety study is expected to yield results later this year.