Allergan Announces Positive Results From Phase 3 Studies Of TrenibotulinumtoxinE In Glabella Lines

(RTTNews) - Allergan Aesthetics, an AbbVie company (ABBV), announced positive 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 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.

According to the company, the primary endpoints of both pivotal Phase 3 studies demonstrated statistical significance for improvement with BoNT/E versus placebo in glabellar line severity on the Facial Wrinkle Scale from baseline at day 7.

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 was demonstrated at 8 hours after drug administration 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.

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.

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