–All primary and secondary endpoints were met for both Phase
3 studies (M21-500 and M21-508).
–Results support
BoNT/E as a novel botulinum neurotoxin serotype E characterized by
a rapid onset of action as early as 8 hours after administration
(earliest assessment time) and short duration of effect within 2-3
weeks.
–If approved,
BoNT/E will be the first neurotoxin of its kind
available to patients.
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
About AbbVie
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.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions and uses of future or conditional verbs,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those expressed or implied in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. Additional
information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations
is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual
Report on Form 10-K, which has been filed with the Securities and
Exchange Commission, as updated by its subsequent Quarterly Reports
on Form 10-Q. AbbVie undertakes no obligation, and specifically
declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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SOURCE AbbVie