–All primary and secondary endpoints were met for second
Phase 3 study (M21-310) and results were consistent with findings
from first Phase 3 study (M21-309).
–Results
support onabotulinumtoxinA as a potential treatment option for
moderate to severe platysma prominence.
–Data will
be included as part of an upcoming U.S. Food and Drug
Administration regulatory submission expected near the end of the
year. If approved, onabotulinumtoxinA will be
the first and only neurotoxin for this indication.
IRVINE,
Calif., Sept. 18, 2023 /PRNewswire/ -- Allergan
Aesthetics, an AbbVie company (NYSE: ABBV), today announced
positive topline results from the second of three Phase 3 clinical
studies evaluating onabotulinumtoxinA (BOTOX® Cosmetic)
for the treatment of moderate to severe platysma prominence
associated with platysma muscle activity (M21-310). Platysma
prominence is an aesthetically unappealing disruption to the neck,
jawline and lower face that is attributed to contraction of the
platysma muscle,1 a superficial, flat muscle in the
lower face and neck.
"We are encouraged by these results, which demonstrated a
significant reduction in the unwanted appearance of vertical band
prominence on the neck and jawline," said Darin Messina, Ph.D., senior vice president,
aesthetics R&D, AbbVie. "These results provide strong evidence
in support of onabotulinumtoxinA as a potential treatment option
for platysma prominence and once approved, will expand our
neurotoxin portfolio into the lower face segment."
The multicenter, randomized, double-blind, placebo-controlled
study evaluated the safety and efficacy of a single treatment of
onabotulinumtoxinA (BOTOX® Cosmetic) versus placebo in
426 adult subjects with moderate to severe platysma prominence. The
primary endpoint was met, demonstrating statistical significance
for improvement with onabotulinumtoxinA (BOTOX®
Cosmetic) versus placebo (p<0.0001) for the improvement in
appearance of platysma prominence from baseline (based on both
investigator and subject assessment). All secondary endpoints were
met, as measured by multiple validated, proprietary
patient-reported outcome (PRO) instruments assessing how bothered
subjects are by the appearance of platysma prominence, psychosocial
impact, treatment expectations and treatment satisfaction from the
subject perspective.
Treatment-emergent adverse events for onabotulinumtoxinA
(BOTOX® Cosmetic) were generally mild and consistent
with known pharmacological effects of onabotulinumtoxinA and
medical literature. OnabotulinumtoxinA (BOTOX® Cosmetic)
has a well-established safety profile and no new safety signals
were observed. Results were consistent with topline results from
the first Phase 3 study (M21-309), announced in April 2023.
"Platysma prominence occurs as part of the natural aging process
and patients need non-invasive treatment options for the appearance
of the lower face and neck and to help improve symmetry between the
upper and lower face," said Sachin
Shridharani, MD, FACS, lead clinical investigator for the
M21-310 study. "Treatment with a proven neurotoxin may help relax
the platysma muscle and thus reduce the appearance of vertical neck
bands and improve jawline definition."
Additional study results will be submitted for presentation at
future medical meetings. A Phase 3 open-label extension study is
ongoing, with results expected later this year. Allergan Aesthetics
will include data from the full Phase 3 study program as part of an
upcoming U.S. Food and Drug Administration (FDA) regulatory
submission expected near the end of the year.
About Platysma Prominence
Platysma prominence is an
aesthetically unappealing disruption to the neck, jawline and lower
face that is attributed to contraction of the platysma
muscle,1 a superficial, flat muscle in the lower face
and neck, which contributes to the formation of facial
expressions.2 In addition to vertical muscular
bands, the contraction of the platysma muscle can lead to the
formation of horizontal lines below the mandible and chin, blunting
the jawline.1,2 While a sign of aging neck,
platysma prominence may become visible at a younger age in some
patients.1 Current treatment options include
surgical approaches such as lower rhytidectomy (neck lift) and
platysmaplasty.1
BOTOX® Cosmetic (onabotulinumtoxinA)
Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is
indicated in adult patients for the temporary improvement in the
appearance of:
- Moderate to severe glabellar lines associated with corrugator
and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with
orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis
activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED
WARNING
WARNING: DISTANT
SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of
BOTOX® Cosmetic and all botulinum toxin
products may spread from the area of injection to produce symptoms
consistent with botulinum toxin effects. These may include
asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia,
dysphonia, dysarthria, urinary incontinence, and breathing
difficulties. These symptoms have been reported hours to weeks
after injection. Swallowing and breathing difficulties can be life
threatening and there have been reports of death. The risk of
symptoms is probably greatest in children treated for spasticity,
but symptoms can also occur in adults treated for spasticity and
other conditions, particularly in those patients who have an
underlying condition that would predispose them to these symptoms.
In unapproved uses and approved indications, cases of
spread of effect have been reported at doses comparable to those
used to treat cervical dystonia and spasticity and at lower
doses.
|
CONTRAINDICATIONS
BOTOX® Cosmetic is
contraindicated in the presence of infection at the proposed
injection site(s) and in individuals with known hypersensitivity to
any botulinum toxin preparation or to any of the components in the
formulation.
WARNINGS AND PRECAUTIONS
Lack of
Interchangeability Between Botulinum Toxin
Products
The potency units of
BOTOX® Cosmetic are specific to the
preparation and assay method utilized. They are not interchangeable
with other preparations of botulinum toxin products and, therefore,
units of biological activity of
BOTOX® Cosmetic cannot be compared to nor
converted into units of any other botulinum toxin products assessed
with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed
Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of
toxin effect associated with dermatologic use of BOTOX®
Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24
Units (for lateral canthal lines), 40 Units (for forehead lines
with glabellar lines), 44 Units (for simultaneous treatment of
lateral canthal lines and glabellar lines), and 64 Units (for
simultaneous treatment of lateral canthal lines, glabellar lines,
and forehead lines) have been reported. Patients or caregivers
should be advised to seek immediate medical care if swallowing,
speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious
adverse reactions, including excessive weakness, dysphagia,
and aspiration pneumonia, with some adverse reactions associated
with fatal outcomes, have been reported in patients who received
BOTOX® injections for unapproved uses. In these
cases, the adverse reactions were not necessarily related to
distant spread of toxin, but may have resulted from the
administration of BOTOX® to the site of injection and/or
adjacent structures. In several of the cases, patients had
pre-existing dysphagia or other significant disabilities. There is
insufficient information to identify factors associated with an
increased risk for adverse reactions associated with the unapproved
uses of BOTOX®. The safety and effectiveness of
BOTOX® for unapproved uses have not been
established.
Hypersensitivity Reactions
Serious and/or
immediate hypersensitivity reactions have been reported. These
reactions include anaphylaxis, serum sickness, urticaria,
soft-tissue edema, and dyspnea. If such reactions occur, further
injection of BOTOX® Cosmetic should be discontinued
and appropriate medical therapy immediately instituted. One fatal
case of anaphylaxis has been reported in which lidocaine was used
as the diluent and, consequently, the causal agent cannot be
reliably determined.
Cardiovascular System
There have been reports
following administration of BOTOX® of adverse events
involving the cardiovascular system, including arrhythmia and
myocardial infarction, some with fatal outcomes. Some of these
patients had risk factors including pre-existing cardiovascular
disease. Use caution when administering to patients with
pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects With
Pre-existing Neuromuscular Disorders
Individuals with
peripheral motor neuropathic diseases, amyotrophic lateral
sclerosis, or neuromuscular junction disorders (eg, myasthenia
gravis or Lambert-Eaton syndrome) should be monitored when given
botulinum toxin. Patients with neuromuscular disorders may be at
increased risk of clinically significant effects including
generalized muscle weakness, diplopia, ptosis, dysphonia,
dysarthria, severe dysphagia, and respiratory compromise from
onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing Difficulties
Treatment
with BOTOX® and other botulinum toxin products can
result in swallowing or breathing difficulties. Patients with
pre-existing swallowing or breathing difficulties may be more
susceptible to these complications. In most cases, this is a
consequence of weakening of muscles in the area of injection that
are involved in breathing or oropharyngeal muscles that control
swallowing or breathing (see Boxed Warning).
Pre-existing Conditions at the Injection Site
Caution
should be used when BOTOX® Cosmetic treatment is
used in the presence of inflammation at the proposed injection
site(s) or when excessive weakness or atrophy is present in the
target muscle(s).
Dry Eye in Patients Treated With BOTOX®
Cosmetic
There have been reports of dry eye associated
with BOTOX® Cosmetic injection in or near the
orbicularis oculi muscle. If symptoms of dry eye (eg, eye
irritation, photophobia, or visual changes) persist, consider
referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral
Diseases
This product contains albumin, a derivative
of human blood. Based on effective donor screening and product
manufacturing processes, it carries an extremely remote risk for
transmission of viral diseases and variant Creutzfeldt-Jakob
disease (vCJD). There is a theoretical risk for transmission of
Creutzfeldt-Jakob disease (CJD), but if that risk actually exists,
the risk of transmission would also be considered extremely remote.
No cases of transmission of viral diseases, CJD or vCJD have ever
been identified for licensed albumin or albumin contained in other
licensed products.
ADVERSE REACTIONS
The most frequently reported
adverse reactions following injection of BOTOX® Cosmetic
for glabellar lines were eyelid ptosis (3%), facial pain (1%),
facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following
injection of BOTOX® Cosmetic for lateral canthal lines
was eyelid edema (1%).
The most frequently reported adverse reactions following
injection of BOTOX® Cosmetic for forehead lines with
glabellar lines were headache (9%), brow ptosis (2%), and eyelid
ptosis (2%).
DRUG INTERACTIONS
Co-administration of
BOTOX® Cosmetic and aminoglycosides or other agents
interfering with neuromuscular transmission (eg, curare-like
compounds) should only be performed with caution as the effect of
the toxin may be potentiated. Use of anticholinergic drugs after
administration of BOTOX® Cosmetic may potentiate
systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin
products at the same time or within several months of each other is
unknown. Excessive neuromuscular weakness may be exacerbated
by administration of another botulinum toxin prior to the
resolution of the effects of a previously administered botulinum
toxin.
Excessive weakness may also be exaggerated by administration of
a muscle relaxant before or after administration of
BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies
or adequate data from postmarketing surveillance on the
developmental risk associated with use of
BOTOX® Cosmetic in pregnant women. There are
no data on the presence of BOTOX® Cosmetic in human or
animal milk, the effects on the breastfed child, or the effects on
milk production.
Please see BOTOX® Cosmetic full Prescribing
Information including Boxed Warning.
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.
References
- Trevidic P, Criollo-Lamilla G. Platysma Bands: Is a Change
Needed in the Surgical Paradigm? Plast Reconstr Surg.
2017;139(1):41-47. doi:10.1097/PRS.0000000000002894.
- de Almeida ART, Romiti A, Carruthers JDA. The Facial
Platysma and Its Underappreciated Role in Lower Face Dynamics and
Contour. Dermatologic Surgery. Aug
2017;43(8):1042-1049. doi:10.1097/Dss.0000000000001135.
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