DUBLIN, Feb. 3, 2020 /PRNewswire/ -- Allergan plc
(NYSE: AGN) announced today its Be The Difference
philanthropic program supporting children and their families who
may benefit from treatment with BOTOX®
(onabotulinumtoxinA) for pediatric upper limb spasticity.
BOTOX® is approved to treat increased muscle stiffness
in children 2 to 17 years of age with upper limb spasticity.
BOTOX® Cosmetic is approved for three aesthetic
indications and BOTOX® is approved for 11 therapeutic
indications in the U.S. During the month of February, every
BOTOX® Cosmetic treatment recorded in Brilliant
Distinctions®, Allergan's loyalty reward program, will
help Allergan contribute up to a total of $500,000 to Foundations that help children across
the country.
Be The Difference will generate awareness and
support children and their caregivers seeking advancement in
pediatric neurological care, while providing loyal aesthetic
patients with an opportunity to support an organization in their
area. In addition to supporting these Foundations by receiving a
BOTOX® Cosmetic treatment, patients can choose to
further their contributions to the campaign by donating their
Brilliant Distinctions® points.
"Many people are familiar with the uses for BOTOX®
Cosmetic, however most are not familiar with all the therapeutic
uses of BOTOX®, particularly for children suffering with
upper limb spasticity. Through the Be the Difference
program, consumers who get treatment with BOTOX®
Cosmetic will support Foundations that help children," says
Carrie Strom, Senior Vice President,
Allergan US Medical Aesthetics. "BOTOX® and
BOTOX® Cosmetic have 14 total indications in the U.S. –
three aesthetic indications for BOTOX® Cosmetic and 11
indications for therapeutic treatment with BOTOX®. We
are proud of how many ways these products and our research can help
people."
In June 2019, BOTOX®
became the first neurotoxin FDA-approved to treat upper limb
spasticity, or muscle stiffness, in children 2 to 17 years of age.
Several months later, BOTOX® was approved by the FDA for
the treatment of muscle stiffness in children 2 to 17 years of age
with lower limb spasticity, excluding spasticity caused by cerebral
palsy.
"As a cosmetic surgeon, I have been treating my patients
with BOTOX® Cosmetic for more than 17 years in my
practice, however I am also a father of two children who suffer
from severe upper limb spasticity due to cerebral palsy and have
seen firsthand the benefits of BOTOX® used for a
therapeutic indication. My aesthetic patients are surprised to
learn that BOTOX® is approved for children with
upper limb spasticity," said Dr. Joseph
Niamtu III, DMD, a cosmetic facial surgeon. "Staying
informed about the resources available and connected to the
healthcare organizations treating pediatric upper limb spasticity
has been crucial in determining the right treatment course for my
boys. I applaud the Be The Difference program as it will
help these Foundations that are so crucial in helping parents
provide their children with the care they need."
Participating Foundations that help children include:
- Children's Hospital of Orange
County (Orange,
Calif.)
- Children's Specialized Hospital (New
Brunswick, N.J.)
- Cincinnati Children's Hospital Medical Center (Cincinnati)
- Dell Children's Medical Center (Austin, Texas)
- Nicklaus Children's Hospital (Miami)
- Rady Children's Hospital (San
Diego)
- Shirley Ryan AbilityLab (Chicago)
- UCSF Benioff Children's Hospitals (Oakland, Calif.)
This past December, Allergan celebrated the 30th anniversary of
BOTOX® since its FDA approval in 1989 for two rare eye
disorders, blepharospasm and strabismus in adults. This milestone
year marked the 14th FDA-approved indication, and the worldwide
distribution of over 100 million vials of BOTOX® and
BOTOX® Cosmetic combined. BOTOX® Cosmetic is
the only treatment of its kind that is FDA approved for temporary
improvement in the appearance of moderate to severe crow's feet,
frown lines, and forehead lines in adults.
Allergan cares about patients and their caregivers and is
focused on supporting programs that improve the health and
well-being of our communities. In 2019, BOTOX® Cosmetic
donated $500,000 to various breast
cancer organizations.
Additionally, since 1998 the Allergan Foundation has donated
$95 million to a wide range of global
philanthropic organizations.
By visiting www.SmallActofKindness.com patients can join the
Be The Difference movement by donating their Brilliant
Distinctions® points to the organizations of their
choice.
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.
CONTACTS:
Allergan:
Investors:
Manisha
Narasimhan, PhD
(862) 261-7488
Media:
Ember Garrett
(714) 246-3525
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SOURCE Allergan plc