DUBLIN, Nov. 18, 2019 /PRNewswire/ -- Allergan plc
(NYSE: AGN), the maker of BOTOX® Cosmetic, has announced
the first-ever National BOTOX® Cosmetic Day kicking off
on November 20. The celebration
recognizes the impact this iconic aesthetic brand, which is the #1
selling treatment of its kind1, has had on American
cultural conversation. Just in time for the holiday season,
National BOTOX® Cosmetic Day is a moment to engage loyal
consumers and healthcare providers, as well as those considering
treatment, in a conversation about owning their look, with fewer
lines, with BOTOX® Cosmetic. BOTOX® Cosmetic
is the only treatment of its kind that is FDA approved for
temporary improvements in moderate to severe crow's feet, frown
lines, and forehead lines in adults.
"Since its approval for aesthetic use, millions of people have
received BOTOX® Cosmetic, and there are still millions
more who want to get more information,"2 explains
Carrie Strom, Senior Vice President
of Medical Aesthetics at Allergan. "National BOTOX®
Cosmetic Day is meant to celebrate this iconic product that has
become a part of American culture and educate consumers who want to
learn more. And just in time for holiday shopping, we are giving
the gift of buy one, get one $100
BOTOX® Cosmetic gift cards!"
As part of National BOTOX® Cosmetic Day, Allergan
will unveil:
- A first-of-its-kind exclusive offer: Purchase a
$100 BOTOX® Cosmetic gift
card and receive a $100
BOTOX® Cosmetic gift card free. This "Buy One, Get One"
offer is one day only, November 20,
with limited quantities. Prior to November
20, consumers can visit
www.botoxcosmeticday.com to sign up for an offer
reminder.
- "Let's BO-TALK" exclusive video content: Jenny Mollen, social media influencers, and
healthcare providers share the moment they knew it was "BO-TIME"
and how BOTOX® Cosmetic has become a central part of
their aesthetic routine.
- BO-Trivia: Did you know that BOTOX®
Cosmetic has become so iconic, you may have even heard it mentioned
in hundreds of movies and TV shows?3 Explore more fun
and shareable facts about the brand and its history on the campaign
website.
- Real results: Before-and-after stories and photos
showcase the natural-looking results that can be achieved with
BOTOX® Cosmetic.
Actress and New York Times
best-selling author Jenny Mollen is
also helping to foster excitement and conversation around National
BOTOX® Cosmetic Day. She is sharing her treatment
experience and encouraging women to own their look and their
decision to explore aesthetic treatments, in a way that is uniquely
Jenny!
"As a working parent of two young boys, things can get hectic,
to say the least! When I'm not running around the house trying to
be super mom or staring at my computer editing my next book, I try
to find time to simply focus on myself," explains Mollen.
"Sometimes, this means breaking away every few months to see my
dermatologist for my next BOTOX® Cosmetic treatment.
This way I can continue to look like myself, just with fewer
lines."
BOTOX® Cosmetic is the only neurotoxin FDA approved
for three treatment areas in adult patients.4 It is the
brand that created a new category in facial aesthetics, since its
first approval for cosmetic use in 2002.5 What many
consumers don't know is that prior to the approval for aesthetic
use in adults, BOTOX® was initially FDA approved in 1989
for two rare eye disorders, blepharospasm and
strabismus.6 BOTOX® was also recently
approved for treatment of pediatric patients (2 to 17 years of age)
with upper limb spasticity and lower limb spasticity, excluding
spasticity caused by cerebral palsy.7
BOTOX® and BOTOX® Cosmetic have product
attributes that are distinct, and combined, have more indications
worldwide than any other neurotoxin.4,7
BOTOX® and BOTOX® Cosmetic have 14 FDA
approved indications,4,7 and over 100 million vials of
BOTOX® and BOTOX® Cosmetic have been
distributed worldwide.8
Recognized by National Day Archives as an official holiday on
the National Day Registry™, BOTOX® Cosmetic Day will be
held annually on the third Wednesday in November.
To learn more about BOTOX® Cosmetic Day and sign up
for an offer reminder, visit www.botoxcosmeticday.com.
IMPORTANT SAFETY INFORMATION
BOTOX® and
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® or 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
There has not been a confirmed serious case of spread of toxin
effect away from the injection site when BOTOX® has been used at
the recommended dose to treat chronic migraine, severe underarm
sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has
been used at the recommended dose to treat frown lines, crow's feet
lines, and/or forehead lines.
Indications
BOTOX® is a prescription medicine that is
injected into muscles and used:
- To treat overactive bladder symptoms such as a strong need to
urinate with leaking or wetting accidents, a strong need to urinate
right away, and urinating often in adults 18 years and older when
another type of medicine (anticholinergic) does not work well
enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and
older with overactive bladder caused by a neurologic disease who
still have leakage or cannot tolerate the side effects after trying
an anticholinergic medication
- To prevent headaches in adults with chronic migraine who have
15 or more days each month with headache lasting 4 or more hours
each day in people 18 years or older
- To treat increased muscle stiffness in elbow, wrist, finger,
thumb, ankle, and toe muscles in people 18 years and older with
upper and lower limb spasticity
- To treat increased muscle stiffness in children 2 to 17 years
of age with upper limb spasticity
- To treat increased muscle stiffness in children 2 to 17 years
of age with lower limb spasticity, excluding spasticity caused by
cerebral palsy
- To treat the abnormal head position and neck pain that happens
with cervical dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (strabismus) or
abnormal spasm of the eyelids (blepharospasm) in people 12 years
and older
BOTOX® is also injected into the skin to treat the symptoms of
severe underarm sweating (severe primary axillary hyperhidrosis)
when medicines used on the skin (topical) do not work well enough
in people 18 years and older.
BOTOX® Cosmetic is a prescription medicine that is injected into
muscles and used to temporarily improve the look of moderate to
severe frown lines between the eyebrows, crow's feet lines, and
forehead lines in adults.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or
effective to prevent headaches in patients with migraine who have
14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX® is safe or effective to treat
increased stiffness in upper limb muscles other than those in the
elbow, wrist, fingers, and thumb, or in lower limb muscles other
than those in the ankle and toes in people 18 years and older.
BOTOX® has not been shown to help people perform task-specific
functions with their upper limbs or increase movement in joints
that are permanently fixed in position by stiff muscles.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or
effective for other types of muscle spasms or for severe sweating
anywhere other than your armpits.
It is not known if BOTOX® Cosmetic is safe or effective for use
more than 1 time every 3 months.
IMPORTANT SAFETY INFORMATION (continued)
BOTOX® and
BOTOX® Cosmetic may cause loss of strength or general muscle
weakness, vision problems, or dizziness within hours to weeks of
taking BOTOX® and BOTOX® Cosmetic. If this happens, do not drive
a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX® or BOTOX® Cosmetic if
you: are allergic to any of its ingredients (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.
Do not receive BOTOX® for the treatment of urinary
incontinence if you: have a urinary tract infection (UTI) or
cannot empty your bladder on your own and are not routinely
catheterizing. Due to the risk of urinary retention (not being able
to empty the bladder), only patients who are willing and able to
initiate catheterization post-treatment, if required, should be
considered for treatment.
Patients treated for overactive bladder:
In clinical
trials, 36 of the 552 patients had to self-catheterize for urinary
retention following treatment with BOTOX® compared to 2 of the 542
treated with placebo. Patients with diabetes mellitus treated with
BOTOX® were more likely to develop urinary retention than
nondiabetics.
Patients treated for overactive bladder due to neurologic
disease:
In clinical trials, 30.6% of patients (33/108) who
were not using clean intermittent catheterization (CIC) prior to
injection, required catheterization for urinary retention following
treatment with BOTOX® 200 Units as compared to 6.7% of patients
(7/104) treated with placebo. The median duration of post-injection
catheterization for these patients treated with BOTOX® 200 Units (n
= 33) was 289 days (minimum 1 day to maximum 530 days) as compared
to a median duration of 358 days (minimum 2 days to maximum 379
days) for patients receiving placebo (n = 7). Among patients not
using CIC at baseline, those with MS were more likely to require
CIC post-injection than those with SCI.
The dose of BOTOX® and BOTOX® Cosmetic is not
the same as, or comparable to, any other botulinum toxin
product.
Serious and/or immediate allergic reactions have been
reported, including itching, rash, red itchy welts, wheezing,
asthma symptoms, or dizziness or feeling faint. Get medical help
right away if you experience symptoms; further injection of BOTOX®
or BOTOX® Cosmetic should be discontinued.
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® or BOTOX® Cosmetic.
Tell your doctor if you have any breathing-related
problems. Your doctor may monitor you for breathing problems
during treatment with BOTOX® for adult spasticity or for detrusor
overactivity associated with a neurologic condition. The risk of
developing lung disease in patients with reduced lung function is
increased in patients receiving BOTOX®.
Cornea problems have been reported. Cornea (surface of
the eye) problems have been reported in some people receiving
BOTOX® for their blepharospasm, especially in people with certain
nerve disorders. BOTOX® may cause the eyelids to blink less, which
could lead to the surface of the eye being exposed to air more than
is usual. Tell your doctor if you experience any problems with your
eyes while receiving BOTOX®. Your doctor may treat your eyes with
drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding
behind the eyeball has been reported in some people receiving
BOTOX® for their strabismus. Tell your doctor if you notice any new
visual problems while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common
colds) have been reported. Bronchitis was reported more
frequently in adults receiving BOTOX® for upper limb spasticity.
Upper respiratory infections were also reported more frequently in
adults with prior breathing related problems with spasticity. In
pediatric patients treated with BOTOX® for upper limb spasticity,
upper respiratory tract infections were reported more frequently.
In pediatric patients treated with BOTOX® for lower limb
spasticity, upper respiratory tract infection was not reported with
an incidence greater than placebo.
Autonomic dysreflexia in patients treated for overactive
bladder due to neurologic disease. Autonomic dysreflexia
associated with intradetrusor injections of BOTOX® could occur in
patients treated for detrusor overactivity associated with a
neurologic condition and may require prompt medical therapy. In
clinical trials, the incidence of autonomic dysreflexia was greater
in patients treated with BOTOX® 200 Units compared with placebo
(1.5% versus 0.4%, respectively).
Tell your doctor about all your medical conditions, including
if you: have or have had bleeding problems; have plans to have
surgery; had surgery on your face; weakness of forehead muscles;
trouble raising your eyebrows; drooping eyelids; any other abnormal
facial change; have symptoms of a urinary tract infection (UTI) and
are being treated for urinary incontinence (symptoms of a urinary
tract infection may include pain or burning with urination,
frequent urination, or fever); have problems emptying your bladder
on your own and are being treated for urinary incontinence; are
pregnant or plan to become pregnant (it is not known if BOTOX® or
BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or
plan to (it is not known if BOTOX® or 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® or 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® or 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 injection; take muscle
relaxants; take allergy or cold medicines; take sleep medicine;
take aspirin-like products or blood thinners.
Other side effects of BOTOX® and BOTOX®
Cosmetic include: dry mouth, discomfort or pain at injection
site, tiredness, headache, neck pain, eye problems: double vision,
blurred vision, decreased eyesight, drooping eyelids, swelling of
your eyelids, dry eyes; drooping eyebrows; and upper respiratory
tract infection. In people being treated for urinary incontinence
other side effects include: urinary tract infection, painful
urination, and/or inability to empty your bladder on your own. If
you have difficulty fully emptying your bladder after receiving
BOTOX®, you may need to use disposable self-catheters to empty your
bladder up to a few times each day until your bladder is able to
start emptying again.
For more information refer to the Medication Guide or talk with
your doctor.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please see BOTOX® full Product
Information, including Boxed Warning
and Medication
Guide.
Please see BOTOX® Cosmetic full Product
Information, including Boxed Warning
and Medication
Guide.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader 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 primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located 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; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
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, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2019. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
References:
- Data on File, Allergan; BOTOX® Cosmetic Annual
Neurotoxin Market Share, 2018.
- Data on File, Allergan, 2019.
- QuoDB. Webpage, (http://www.quodb.com/search/botox).
October 2019.
- BOTOX® Cosmetic Prescribing Information, 2019.
- Department of Health and Human Services FDA-Approval Letter for
BOTOX® Cosmetic for Glabellar Lines, 2002.
- Food and Drug Association. Orphan Drug Designations and
Approvals.
(https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=483),
November 2019.
- BOTOX® Prescribing Information, 2019.
- Data on File, Allergan; BOTOX®/BOTOX®
Cosmetic Combined Sales History with Units, 2019
© 2019 Allergan. All rights reserved. All trademarks are the
property of their respective owners.
CONTACTS:
Allergan:
Investors:
Manisha Narasimhan, PhD
(862) 261-7488
Media:
Ember Garrett
(714) 246-3525
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SOURCE Allergan plc