BOTOX® Cosmetic (onabotulinumtoxinA) Celebrates 10-Year Anniversary of U.S. Food and Drug Administration Approval
IRVINE, Calif.--(BUSINESS WIRE)--
Allergan, Inc. (NYSE: AGN) announced today that April 15, 2012 will mark
the 10-year anniversary of the U.S. Food and Drug Administration's (FDA)
approval of BOTOX® Cosmetic (onabotulinumtoxinA) to
improve the look of moderate to severe frown lines between the
eyebrows in patients age 18-65.
"When approved by the FDA in 2002, BOTOX® Cosmetic changed
the way that physicians could treat patients who were interested in
improving the appearance of their vertical frown lines between the
brows," said David E.I. Pyott, Chairman of the Board, President and CEO,
Allergan, Inc. "BOTOX® Cosmetic has become the number-one
neuromodulator in the United States and the number of patients
considering talking to their doctor about treatment has more than
quadrupled to 5.8 million since 2002.1, 2"
BOTOX® secured its first FDA approval more than 22 years ago
as a treatment for two rare eye muscle disorders, making it the first
product of its kind approved in the world. In 2002, the same formulation
with dosing specific to frown lines was approved under the name BOTOX®
Cosmetic.
"The FDA approval of BOTOX® Cosmetic enhanced the practice of
plastic surgery by providing plastic surgeons with a new treatment
option for patients seeking to reduce the appearance of vertical frown
lines between the eyebrows," said Malcolm Z. Roth, MD, president of the
American Society of Plastic Surgeons.
In the decade since BOTOX® Cosmetic was approved, aesthetic
specialty physicians — which include dermatologists, oculoplastic
surgeons and facial plastic surgeons — have developed extensive
experience in the art and science of administering BOTOX®
Cosmetic to yield predictable results for their patients. These
physicians have performed approximately 11 million BOTOX®
Cosmetic treatment sessions since 2002 and have also contributed to the
extensive clinical database demonstrating the safety and efficacy of the
drug.
"The approval of BOTOX® Cosmetic in 2002 dramatically changed
our ability to treat our patients by giving them an effective option to
treat the appearance of moderate to severe vertical frown lines with a
minimally invasive procedure," said Susan Weinkle, MD, president of the
American Society for Dermatologic Surgery. "BOTOX® Cosmetic
has become more accepted by the public, and this treatment has brought
more patients into aesthetic practices to learn about other treatments
available."
About BOTOX® (onabotulinumtoxinA)
BOTOX® is a prescription-only medical product that contains
tiny amounts of highly purified botulinum toxin protein refined from the
bacterium, Clostridium botulinum. BOTOX® has a unique,
protected molecular structure that stabilizes the core toxin in BOTOX®
from degradation. When injected at FDA-approved and labeled doses into a
specific muscle or gland, BOTOX® is expected to diffuse
locally and produce a safe and effective result by producing a localized
and temporary reduction in the overacting muscle or gland, usually
lasting up to approximately three to ten months depending on the
indication and on the individual patient.
BOTOX® was first approved by the FDA more than 22 years ago
for the treatment of strabismus and blepharospasm, two eye muscle
disorders, making it the first botulinum toxin type A product approved
in the world. Since its first approval in 1989, BOTOX® has
been recognized by regulatory authorities worldwide as an effective
treatment for 25 different indications in approximately 85 countries,
benefiting millions of patients worldwide. In the United States, BOTOX®
is also approved to treat seven medical conditions, including the
abnormal head position and neck pain that happens with cervical dystonia
(CD) in adults; symptoms of severe underarm sweating (severe primary
axillary hyperhidrosis) when medicines used on the skin (topical) do not
work well enough; for the treatment of increased muscle stiffness in
elbow, wrist, and finger muscles in adult patients with upper limb
spasticity; for the prophylactic treatment of headaches in adults with
Chronic Migraine, a distinct and severe neurological disorder
characterized by patients who have a history of migraine and suffer from
headaches on 15 or more days per month with headaches lasting four hours
a day or longer; and most recently, for the treatment of urinary
incontinence due to detrusor overactivity associated with a neurologic
condition (e.g. spinal cord injury (SCI), multiple sclerosis (MS)) in
adults who have an inadequate response to or are intolerant of an
anticholinergic medication.
In addition to its therapeutic uses, the same formulation of BOTOX®
with dosing specific to moderate to severe glabellar lines was approved
by the FDA in 2002 under the trade name BOTOX® Cosmetic
(onabotulinumtoxinA). BOTOX® Cosmetic is indicated for the
temporary improvement in the appearance of moderate to severe glabellar
lines (frown lines between the eyebrows) associated with corrugator
and/or procerus muscle activity in adult patients up to 65 years of age.
In addition to approximately 21 years of clinical experience, the safety
and efficacy of BOTOX® have been well-established in
approximately 65 randomized, placebo-controlled clinical trials and in
approximately 15,000 patients treated with BOTOX® and BOTOX®
Cosmetic in Allergan's clinical trials.3 Worldwide,
approximately 30 million vials of BOTOX® and BOTOX®
Cosmetic have been distributed and approximately 29 million treatment
sessions have been performed over the past 20 years (1990-2010).4
With approximately 2,500 articles on BOTOX® and BOTOX®
Cosmetic in scientific and medical journals,5 BOTOX® neurotoxin
is one of the most widely researched medicines in the world.
BOTOX® (onabotulinumtoxinA) & BOTOX®
Cosmetic Important Information
Indications
BOTOX® is a prescription medicine that is injected into
muscles and used:
to treat leakage of urine (incontinence) in adults with overactive
bladder due to neurologic disease who still have leakage or experience
too many 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, and finger
muscles in people 18 years and older with upper limb spasticity
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 improve the look of moderate to severe
frown lines between the eyebrows (glabellar lines) in people 18 to 65
years of age for a short period of time (temporary).
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® and BOTOX® Cosmetic
are safe or effective to treat increased stiffness in upper-limb muscles
other than those in the elbow, wrist, and fingers, or to treat increased
stiffness in lower-limb muscles. 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. Treatment with BOTOX® is not meant to replace
your existing physical therapy or other rehabilitation that your doctor
may have prescribed.
It is not known whether BOTOX® and BOTOX® Cosmetic
are safe or effective for severe sweating anywhere other than your
armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic
may cause serious side effects that can be life threatening. Call
your doctor or 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 (dysphonia), trouble saying words clearly (dysarthria),
loss of bladder control, trouble breathing, trouble swallowing. If
this happens, do not drive a car, operate machinery, or do other
dangerous activities
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, or strabismus, urinary incontinence in adults with
overactive bladder due to neurologic disease, or when BOTOX®
Cosmetic has been used at the recommended dose to treat frown lines.
Do not take BOTOX® or BOTOX®
Cosmetic if you: are allergic to any of the ingredients in BOTOX®
or 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.
Do not take 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.
The dose of BOTOX® and BOTOX®
Cosmetic is not the same as, or comparable to, another botulinum toxin
product.
Serious and/or immediate allergic reactions have been reported.
These include itching, rash, red itchy welts, wheezing, asthma symptoms,
or dizziness or feeling faint. Tell your doctor or get medical help
right away if you experience any such symptoms; further injection of
BOTOX® or BOTOX® Cosmetic should be
discontinued.
Tell your doctor about all your muscle or nerve conditions such
as amyotrophic lateral sclerosis (ALS or Lou Gehrig's
disease), myasthenia gravis, or Lambert-Eaton syndrome, as you
may be at increased risk of serious side effects including severe
dysphagia (difficulty swallowing) and respiratory compromise (difficulty
breathing) from typical doses of BOTOX® or BOTOX®
Cosmetic.
Tell your doctor if you have any breathing-related problems. Your
doctor will want to monitor you for any breathing problems during your
treatment with BOTOX® for upper limb spasticity.
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 people
receiving BOTOX® for their upper limb spasticity. Upper
respiratory infections (common colds) were also reported more frequently
in people with prior breathing-related problems.
Human albumin and spread of viral diseases. BOTOX® and
BOTOX® Cosmetic contain albumin, a protein component
of human blood. The potential risk of spreading viral diseases (eg,
Creutzfeldt-Jakob disease [CJD]) via human serum albumin is extremely
rare. No cases of viral diseases or CJD have ever been reported in
association with human serum albumin.
Tell your doctor about all your medical conditions, including if you
have: plans to have surgery; had surgery on your face; weakness of
forehead muscles, such as trouble raising your eyebrows; drooping
eyelids; any other abnormal facial change; pain or burning with
urination, frequent urination, 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 breastfeed (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 nonprescription medicines, vitamins, and herbal
products. 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.
Especially 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 (be sure your
doctor knows 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.
Other side effects of BOTOX® and 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, swelling of your eyelids, and dry eyes.
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.
For BOTOX® and BOTOX®
Cosmetic full Product
Information including Boxed Warning and Medication
Guide click here.
About Allergan, Inc.
Allergan is a multi-specialty health care company established more than
60 years ago with a commitment to uncover the best of science and
develop and deliver innovative and meaningful treatments to help people
reach their life's potential. Today, we have approximately 10,000 highly
dedicated and talented employees, global marketing and sales
capabilities with a presence in more than 100 countries, a rich and
ever-evolving portfolio of pharmaceuticals, biologics, medical devices
and over-the-counter consumer products, and state-of-the-art resources
in R&D, manufacturing and safety surveillance that help millions of
patients see more clearly, move more freely and express themselves more
fully. From our beginnings as an eye care company to our focus today on
several medical specialties, including eye care, neurosciences, medical
aesthetics, medical dermatology, breast aesthetics, obesity intervention
and urologics, Allergan is proud to celebrate more than 60 years of
medical advances and proud to support the patients and physicians who
rely on our products and the employees and communities in which we live
and work.
Forward-Looking Statements
This press release contains "forward-looking statements," including the
statements by Mr. Pyott, Dr. Roth and Dr. Weinkle, and other statements
regarding the safety, effectiveness and adverse events associated with
BOTOX® Cosmetic. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results
could vary materially from Allergan's expectations and projections.
Risks and uncertainties include, among other things, general industry
and pharmaceutical market conditions; technological advances and patents
attained by competitors; challenges inherent in the research and
development and regulatory processes; challenges related to new product
marketing, such as the unpredictability of market acceptance for new
pharmaceutical products and/or the acceptance of new indications for
such products; inconsistency of treatment results among patients;
potential difficulties in manufacturing a new product; general economic
conditions; and governmental laws and regulations affecting domestic and
foreign operations. Additional information concerning the
above-referenced risk factors and other risk factors can be found in
press releases issued by Allergan, as well as Allergan's public periodic
filings with the U.S. Securities and Exchange Commission, including the
discussion under the heading "Risk Factors" in Allergan's 2011 Annual
Report on Form 10-K. Copies of Allergan's press releases and additional
information about Allergan are available at www.allergan.com
or you can contact the Allergan Investor Relations Department by calling
714-246-4636.
© 2012 Allergan, Inc. Irvine, CA 92612. ® marks owned by
Allergan, Inc. All rights reserved. APC25HU12Myobloc®
is a registered trademark of Solstice Neurosciences, Inc.Dysport®
is a registered trademark of Ipsen Biopharm, Ltd.Xeomin®
is a registered trademark of Merz Pharma Gmbh & Co.
_____________________________
1 BOTOX Cosmetic Quantitative Consumer Segmentation 2002, Pg
102 Allergan data on file; 6MM BOTOX® Cosmetic
Considering, Pg 13 Allergan data on file; Medical
Affairs4 Allergan data on file; Global Regulatory
Affairs5 Allergan data on file; Global Literature &
Information Services
Allergan ContactsBonnie Jacobs (856) 912-9965; (714)
246-5134; Jacobs_bonnie@allergan.com
(media)Kellie Lao (714) 262-1088; (714) 246-2278; lao_kellie@allergan.com
(media)
Source: Allergan, Inc.
News Provided by Acquire Media