DUBLIN, Sept. 14, 2018 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced clinical study results of higher doses
of BOTOX® Cosmetic compared to BOTOX®
Cosmetic 20 unit dose at week 24 in patients with moderate to
severe glabellar lines.
Allergan conducted this trial to evaluate the duration of effect
and safety of BOTOX® Cosmetic 40, 60, and 80 unit doses
versus BOTOX® Cosmetic 20 unit dose in patients with
moderate to severe glabellar lines. The primary efficacy endpoint
was met and was statistically significant for BOTOX®
Cosmetic 40 and 80 units versus 20 unit in 226 subjects at 24 weeks
(analysis, ≥1 point improvement in Facial Wrinkle Scale (FWS) from
baseline assessed by Investigator at Maximum Frown).
In this trial, 32% of patients were responders at week 24 in the
BOTOX® Cosmetic 40 unit group, 30.6% in the
BOTOX® Cosmetic 60 unit group, and 38.5% in the
BOTOX® Cosmetic 80 unit group as compared to 16% in the
20 unit group. The dose effect was observed across additional
outcome variables.
For responders with a > 1 point improvement, the time to
return to baseline also demonstrated a dose-effect. The
median time on the Kaplan-Meier curve was 19.7 weeks for 20 Units
and 24.0 weeks for 40 Units, suggesting the median benefit of 40
units is between 20 and 24 weeks.
"These study results help us better understand the
BOTOX® Cosmetic dose duration of effect and confirm our
hypothesis that higher doses of botulinum toxin produce a longer
duration of treatment effect for the treatment of glabellar lines,"
said David Nicholson, Chief Research
and Development Officer, Allergan. "Based on this data, doubling
the dose of botulinum toxin extends the duration of effect to 24
weeks in approximately one-third of patients."
The higher doses of BOTOX® Cosmetic were safe and
well tolerated. In a total 233 patients evaluable for safety,
there was one serious adverse event (SAE) unrelated to treatment.
Overall treatment related adverse events (AEs) compare favorably
with USPI labeled AEs and no new safety signals were
identified. Across all studied doses there was 1 case (0.4%)
eyelid ptosis at 80 unit and 1 case (0.4%) eyebrow ptosis at 20
unit."
About Glabellar Lines
The Glabella is the skin between the eyebrows and above the
nose. Glabellar Lines, often called "frown lines", are vertical
lines that develop between the eyebrows and may appear as a single
vertical line or as two or more lines and may also appear angled
toward the inner corners of the eyebrows. When we frown, the
muscles of the lower forehead contract in a downward direction,
causing the skin between the eyebrows to crease. Lines are
formed by the repeated action of frowning due to the lack of
elasticity to the skin. Age, sun exposure, and genetics are
contributing factors.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical leader. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceutical, device,
biologic, surgical and regenerative medicine products for patients
around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of
research and development, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. With this approach, Allergan has built one of the
broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues'
commitment to being Bold for Life. Together, we build bridges,
power ideas, act fast and drive results for our customers and
patients around the world by always doing what is right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives every day.
For more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan's current expectations depending
upon a number of factors affecting Allergan's business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures;
uncertainty associated with financial projections, debt reduction,
projected cost reductions, projected synergies, restructurings,
increased costs, and adverse tax consequences; difficulties or
delays in manufacturing; and other risks and uncertainties detailed
in Allergan's periodic public filings with the Securities and
Exchange Commission, including but not limited to Allergan's Annual
Report on Form 10-K for the year ended December 31, 2017 and Allergan's Quarterly Report
on Form 10-Q for the period ended June 30,
2018. Except as expressly required by law, Allergan
disclaims any intent or obligation to update these forward-looking
statements.
Approved Uses
BOTOX® Cosmetic is a
prescription medicine that is injected into muscles and used to
temporarily improve the look of moderate to severe forehead lines,
crow's feet lines, and frown lines between the eyebrows in
adults.
IMPORTANT SAFETY INFORMATION
BOTOX®
Cosmetic may cause serious side effects that can be life
threatening. Get medical help right away if you have any of these
problems any time (hours to weeks) after injection of
BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in loss
of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last for
several months.
- Spread of toxin effects. The effect of botulinum toxin
may affect areas away from the injection site and cause serious
symptoms including: loss of strength and all-over muscle weakness,
double vision, blurred vision and drooping eyelids, hoarseness or
change or loss of voice, trouble saying words clearly, loss of
bladder control, trouble breathing, and trouble swallowing.
BOTOX® Cosmetic dosing units are not the same as,
or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin
effect when BOTOX® Cosmetic has been used at the
recommended dose to treat frown lines, crow's feet lines, and/or
forehead lines.
BOTOX® Cosmetic may cause loss of strength or general
muscle weakness, vision problems, or dizziness within hours to
weeks of taking BOTOX® Cosmetic. If this happens, do
not drive a car, operate machinery, or do other dangerous
activities.
Serious and/or immediate allergic reactions have been
reported. They include: itching, rash, red itchy welts,
wheezing, asthma symptoms, or dizziness or feeling faint. Get
medical help right away if you are wheezing or have asthma
symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are
allergic to any of the ingredients in BOTOX® Cosmetic
(see Medication Guide for ingredients); had an allergic reaction to
any other botulinum toxin product such as
Myobloc® (rimabotulinumtoxinB),
Dysport® (abobotulinumtoxinA), or
Xeomin® (incobotulinumtoxinA); have a skin
infection at the planned injection site.
Tell your doctor about all your muscle or nerve
conditions, such as ALS or Lou
Gehrig's disease, myasthenia gravis, or Lambert-Eaton
syndrome, as you may be at increased risk of serious side effects
including difficulty swallowing and difficulty breathing from
typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions,
including: plans to have surgery; had surgery on your face; have
trouble raising your eyebrows; drooping eyelids; any other abnormal
facial change; are pregnant or plan to become pregnant (it is not
known if BOTOX® Cosmetic can harm your unborn baby); are
breast-feeding or plan to (it is not known if BOTOX®
Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Using BOTOX® Cosmetic with
certain other medicines may cause serious side effects. Do not
start any new medicines until you have told your doctor that you
have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin
product in the last 4 months; have received injections of botulinum
toxin such as Myobloc®,
Dysport®, or Xeomin® in the
past (tell your doctor exactly which product you received); have
recently received an antibiotic by injection; take muscle
relaxants; take an allergy or cold medicine; take a sleep medicine;
take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include:
dry mouth; discomfort or pain at the injection site; tiredness;
headache; neck pain; and eye problems: double vision, blurred
vision, decreased eyesight, drooping eyelids and eyebrows, swelling
of your eyelids and dry eyes.
For more information refer to the Medication Guide or talk with
your doctor.
To report a side effect, please call Allergan at
1-800-678-1605.
Please see BOTOX® Cosmetic
full Product Information including Boxed
Warning and Medication Guide.
CONTACTS:
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Allergan:
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Investors:
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Daphne
Karydas
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(862)
261-8006
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Karina
Calzadilla
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(862)
261-7328
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Media
Relations:
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Amy Rose
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(862)
289-3072
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Fran
DeSena
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(862)
261-8820
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SOURCE Allergan plc