DUBLIN, Dec. 16, 2019 /PRNewswire/ -- Allergan plc (NYSE:
AGN) is commemorating today the beginning of the 30th
anniversary celebration for BOTOX® this year with the
ringing of the New York Stock Exchange opening bell. Over the
past 30 years, more than 100 million vials of BOTOX® and
BOTOX® Cosmetic have been manufactured worldwide,
providing a trusted and effective treatment option for various
therapeutic and aesthetic uses. With two additional U.S. Food and
Drug Administration (FDA) approvals this year for therapeutic
indications of pediatric upper limb spasticity and pediatric lower
limb spasticity, excluding spasticity caused by cerebral palsy,
BOTOX® and BOTOX® Cosmetic now proudly hold
14 therapeutic and aesthetic indications combined, reinforcing its
leadership in neurotoxin science.
"This incredible milestone underscores our constant focus on
innovation and motivates us to further build on our 30 years of
research and development efforts for BOTOX®," said
Mitchell F. Brin, M.D., Senior Vice
President Global Drug Development, Chief Scientific Officer,
BOTOX® & Neurotoxins. "For three decades, our team
has been dedicated to manufacturing and delivering
BOTOX® from an unparalleled state-of-the-art facility,
abiding to the strictest quality and safety standards. As we now
look forward to the next 30 years and beyond, we maintain our
commitment to serve patients worldwide across a wide spectrum of
diseases and clinical needs."
BOTOX® was first FDA-approved in 1989 for two rare
eye muscle disorders – blepharospasm and strabismus in adults,
making it the world's first botulinum toxin type A product to be
approved. Since then, BOTOX® has continued to innovate
which has led to the FDA's approval of 11 therapeutic indications,
including Chronic Migraine, overactive bladder, leakage of urine
(incontinence) associated with a neurologic condition, cervical
dystonia, adult upper limb spasticity, adult lower limb spasticity,
severe underarm sweating (axillary hyperhidrosis), and most
recently, pediatric upper limb spasticity and pediatric lower limb
spasticity, excluding spasticity caused by cerebral palsy. Allergan
remains committed to pioneering research and development efforts to
continue leading innovation in neurotoxins, and to providing robust
resources and services to ensure BOTOX® is accessible
and affordable to patients, including the BOTOX® Savings
Program.
"Our ongoing collaboration with Allergan and the approval of
BOTOX® in 2000 as a first-line treatment for cervical
dystonia have been very important to us and have brought hope to
the cervical dystonia community," said Art
Kessler, President of the Board, Dystonia Medical Research
Foundation (DMRF). "We value our shared commitment to raising
awareness of the disease, potential treatment options, and the
importance of talking to your doctor."
As the first neurotoxin treatment to be approved for aesthetic
use, BOTOX® Cosmetic remains a category leader, backed
by 17 years of data. Receiving its first FDA approval in 2002 to
temporarily improve the appearance of moderate to severe glabellar
lines (frown lines between the eyebrows), BOTOX®
Cosmetic is also approved for the temporary improvement in the
appearance of moderate to severe crow's feet and forehead lines in
adults.
With more than 3,900 articles on BOTOX® and
BOTOX® Cosmetic published in scientific and medical
journals, and over 115 sponsored studies, BOTOX®
neurotoxin is one of the most widely researched medicines in the
world. BOTOX® continues to be a leader in its category
as it carries 28 indications worldwide, with approval for use in
100 different countries. Backed by strong science and a global
presence, BOTOX® proudly embraces its past while boldly
looking to the future. Learn more at
BOTOXEndlessInnovation.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.
CONTACTS:
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Allergan:
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Investors:
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Manisha Narasimhan,
PhD
|
|
(862)
261-7162
|
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Media:
|
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Lisa Brown
|
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(862)
261-7320
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Lisa Kim
|
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(714)
246-3843
|
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SOURCE Allergan plc