The neurotoxin is characterized by a rapid onset of action as early as eight hours after administration and a shorter duration of effect of two to three weeks.
AbbVie announced submission of a Biologics License Application to the US Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines.
TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as eight hours after administration and a shorter duration of effect of two to three weeks.
“The submission provides evidence of TrenibotE’s differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin,” says Darin Messina, PhD, senior vice president of aesthetics research and development at AbbVie, in a release. “TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category.”
New patients wanting to experience the aesthetic benefits of a neurotoxin cite “fear of looking unnatural” as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with Botox.
Clinical Trial Results
The Biologics License Application submission is supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines and a phase 3 open-label safety study. All primary and secondary endpoints of the phase 3 studies were met, with a rapid onset of action as early as eight hours after drug administration and observed efficacy duration for two to three weeks.
Treatment-emergent adverse events for TrenibotE were similar to placebo, both as a single treatment and up to three consecutive treatments. Topline data from the phase 3 pivotal studies were previously shared.
“Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment,” says Cheryl Burgess, MD, FAAD, lead clinical investigator for one of the phase 3 studies, in a release. “Treatment with a product offering rapid onset of effect and short duration of action could help address this barrier and empower confidence for patients exploring their aesthetics treatment journey with innovation from the makers of Botox Cosmetic.”
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