NORTH CHICAGO, Ill.,
July 29, 2021 /PRNewswire/ --
Allergan, an AbbVie (NYSE: ABBV) company, today announced that the
U.S. Food and Drug Administration (FDA) has approved a label
expansion of BOTOX® to include eight new muscles for the
treatment of upper limb spasticity in adults. The new muscles
for treatment include additional muscles of the elbow and forearm
(brachialis, brachioradialis, pronator teres, and pronator
quadratus), as well as intrinsic hand muscles (lumbricals and
interossei) and thumb muscles (flexor pollicis brevis and opponens
pollicis). The label now includes the use of ultrasound as a muscle
localization technique in adult spasticity.
"Today's announcement is especially important because spasticity
is a disabling neurological condition that can have a significant
impact on a patient's quality of life," said Mitchell F. Brin, M.D., Senior Vice President,
Chief Scientific Officer, BOTOX® & Neurotoxins,
AbbVie. "This label expansion not only adds to our rich
history in neurotoxin science, but also reinforces the role of
BOTOX® in upper limb spasticity treatment.
BOTOX® provides an evidence-based dosing strategy to
meet the clinical needs of providers and their patients."
Spasticity in adults is commonly caused by stroke, multiple
sclerosis, spinal cord injury, cerebral palsy, and traumatic brain
injury. Individuals with spasticity experience stiffness in the
muscles of their upper and/or lower limbs, and may have difficulty
with voluntary control. Upper limb spasticity can manifest as a
bent elbow, an arm pressed against the chest, or a curled-in hand
with a clenched fist, significantly hindering the patient's ability
to perform everyday activities. This can result in difficulty with
posture and positioning, and severely interfere with normal
muscular movement and function.
BOTOX® has been proven to significantly reduce muscle
stiffness and is indicated for the treatment of spasticity in
patients 2 years of age and older. This expanded BOTOX®
dosing guidance provides physicians the ability to treat based on
clinical assessment of a patient's spasticity and anatomy while
staying within the BOTOX® maximum cumulative dose of 400
Units in a 3-month period in adults. BOTOX® has not been
shown to improve upper extremity functional abilities or range of
motion at a joint affected by a fixed contracture. The safety
profile of BOTOX® in adult upper limb spasticity remains
the same, with the most common adverse reactions including nausea,
fatigue, bronchitis, pain in extremity and muscular weakness.
"BOTOX® has demonstrated efficacy and safety for
spasticity management at clinically proven doses,"
said Kimberly Heckert,
M.D., Director, Spasticity Management Fellowship, Thomas Jefferson University of Philadelphia. "This label expansion
offers physicians and their patients living with spasticity another
important tool as part of a comprehensive treatment plan for
spasticity management."
BOTOX® Training and Support
Programs
Allergan offers a variety of expert-based BOTOX® education and
technical training programs to help physicians enhance their
clinical skills and injection practices. These training programs
focus on using guidance techniques, such as EMG, nerve stimulation,
and now ultrasound, to help localize muscles for BOTOX®
injection in adults with spasticity. In addition, the company is
committed to providing resources and services, such as the
BOTOX® Savings Program, to help ensure BOTOX®
is accessible and affordable to patients.
About BOTOX®
BOTOX® was first approved by the FDA in 1989 for
two rare eye muscle disorders –
blepharospasm and strabismus in adults. Today,
BOTOX® is FDA-approved for 12 therapeutic
indications, including chronic migraine, overactive bladder,
leakage of urine (incontinence) due to overactive bladder caused by
a neurologic condition in adults, cervical dystonia, adult and
pediatric spasticity, severe underarm sweating (axillary
hyperhidrosis), and pediatric detrusor overactivity associated with
a neurologic condition.
BOTOX® (onabotulinumtoxinA)
Important Information
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 (urge urinary
incontinence), a strong need to urinate right away (urgency), and
urinating often (frequency) 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 treat overactive bladder due to a neurologic disease in
children 5 years of age and older when another type of medicine
(anticholinergic) does not work well enough or cannot be taken
- 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 people 2 years of age
and older with 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 of
age 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.
It is not known whether
BOTOX® is safe and
effective to prevent headaches in
patients with migraine
who have 14 or fewer headache days
each month (episodic migraine).
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® is
safe and effective for severe sweating anywhere other
than your armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® 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®:
-
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, or strabismus.
BOTOX® may cause loss
of strength or general muscle weakness, vision
problems, or dizziness within hours
to weeks of taking BOTOX®. If
this happens, do not drive a car, operate
machinery, or do other dangerous activities.
Do not
receive BOTOX® if you: are
allergic to any of the ingredients
in BOTOX® (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.
The median duration of post-injection catheterization for these
patients treated with BOTOX® 100 Units (n = 36) was 63
days (minimum 1 day to maximum 214 days) as compared to a median
duration of 11 days (minimum 3 days to maximum 18 days) for
patients receiving placebo (n = 2).
Patients with diabetes mellitus
treated with BOTOX® were
more likely to develop
urinary retention than nondiabetics.
Adult 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® is not
the same as, or comparable to, another
botulinum toxin product.
Serious and/or immediate allergic reactions have been
reported, including itching, rash, red itchy welts, wheezing,
asthma symptoms, dizziness, or feeling faint. Get medical help
right away if you experience symptoms; further injection of BOTOX®
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®.
Tell your doctor if you have any
breathing-related problems. Your
doctor may monitor you for breathing problems
during treatment with BOTOX® for
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 infections were not reported more
frequently 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 adult
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®
can harm your unborn baby); are breastfeeding or
plan to (it is
not known if BOTOX® 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® 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® in the past.
Tell your doctor
if you 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® include: dry mouth,
discomfort or pain at the 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 adults
being treated for urinary incontinence, other side effects include
urinary tract infection and painful urination. In children being
treated for urinary incontinence, other side effects include
urinary tract infection and bacteria in the urine. If you have
difficulty fully emptying your bladder on your own 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.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues
today and address the medical challenges of tomorrow. We strive to
have a remarkable impact
on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye
care, virology, women's health and gastroenterology, in addition to products and services across
its Allergan Aesthetics portfolio. For more information about
AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions, among
others, generally identify forward-looking statements. AbbVie
cautions that these forward-looking statements are subject to risks
and uncertainties that may cause actual results to differ
materially from those indicated in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
failure to realize the expected benefits from AbbVie's acquisition
of Allergan plc ("Allergan"), failure to promptly and effectively
integrate Allergan's businesses, competition from other products,
challenges to intellectual property, difficulties inherent in the
research and development process, adverse litigation or government
action, changes to laws and regulations applicable to our industry
and the impact of public health outbreaks, epidemics or pandemics,
such as COVID-19. Additional information about the economic,
competitive, governmental, technological and other factors that may
affect AbbVie's operations is set forth in Item 1A, "Risk Factors,"
of AbbVie's 2020 Annual Report on Form 10-K, which has been filed
with the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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