NORTH CHICAGO, Ill.,
Jan. 15, 2021 /PRNewswire/ -- Allergan Aesthetics and
Allergan, an AbbVie company (NYSE: ABBV), announced today that
scientific and clinical experts in the field of neurotoxins will
present results from 16 abstracts spanning pre-clinical and
clinical studies evaluating key safety and efficacy of BOTOX®
(onabotulinumtoxinA) across multiple therapeutic and cosmetic
indications. Data includes long-term immunogenicity rates across 10
therapeutic and aesthetic indications, analyses from the Adult
Spasticity International Registry (ASPIRE) study and Cervical
Dystonia Patient Registry for BOTOX® Efficacy (CD-PROBE), reviewing
adherence to onabotulinumtoxinA treatment in patients with
spasticity and efficacy and tolerability in patients with
cervical dystonia, respectively. Also to be presented are data on
incontinence product use and associated costs in patients with
overactive bladder treated with onabotulinumtoxinA. Additionally,
results from a randomized controlled clinical trial on the efficacy
and safety of three active doses of onabotulinumtoxinA for the
treatment of neurogenic detrusor overactivity in children and
findings from a study on the safety, pharmacodynamic response and
treatment satisfaction, with increasing doses of onabotulinumtoxinA
in patients with moderate to severe dynamic glabellar lines will be
presented. These data will be presented at the TOXINS 2021 Virtual
Conference, organized by The International Neurotoxin Association
(INA), January 16-17.
"We continue to be deeply committed to advancing research of
neurotoxins and are pleased to be able to share the depth and
breadth of our latest data on BOTOX® and BOTOX® Cosmetic at the
TOXINS 2021 Virtual Conference," said Mitchell F. Brin, M.D.,
Senior Vice President, Chief Scientific Officer, BOTOX® &
Neurotoxins, AbbVie. "With over 30 years in the neurotoxin space,
we are excited to further build on this heritage as part of AbbVie.
It allows us to support health professionals in meeting the
individual needs of patients around the world on an even greater
scale, both now and in the future."
The abstracts are expected to be published online in a
supplement of the journal Toxicon on January 16, 2021
with open access for six months after the conference. They will
also be presented virtually over the course of the two-day
conference.
The TOXINS 2021 Virtual Poster Hall opens on January 16 and will remain open to conference
attendees for 60 days post-conference. AbbVie abstracts being
presented at the conference are outlined below.
Adherence to
OnabotulinumtoxinA Treatment in Patients with Spasticity from the
ASPIRE Study
|
Sustained Efficacy
and Tolerability of OnabotulinumtoxinA in Naive and Non-naive
Patients with Cervical Dystonia: Preliminary Completer Analysis
from CD-PROBE
|
Reduction in
Incontinence Product Use and Associated Cost Savings After
OnabotulinumtoxinA Treatment in Patients with Overactive
Bladder
|
Lower Limb Injections
of OnabotulinumtoxinA: Improvement in Gait and Treatment Goal
Achievement in Pediatric Patients with Cerebral Palsy
|
Efficacy and Safety
of an Alternative OnabotulinumtoxinA Injection Paradigm for
Overactive Bladder: Final Double-Blind and Open-Label Results in
Female Patients
|
Efficacy and Safety
of Three Active Doses of OnabotulinumtoxinA for the Treatment of
Neurogenic Detrusor Overactivity in Children: Results of a
Randomized Controlled Clinical Trial
|
Real-life Use of
OnabotulinumtoxinA for Symptom Relief in Patients with Chronic
Migraine: REPOSE Study German Population
|
Safety,
Pharmacodynamic Response, and Treatment Satisfaction with
OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects with Moderate
to Severe Dynamic Glabellar Lines
|
Safety and Efficacy
of OnabotulinumtoxinA for Treatment of Masseter Muscle Hypertrophy:
Results from a Phase 2 Dose-Escalation Study
|
Pregnancy Outcomes
Following Exposure to OnabotulinumtoxinA Update: 29 Years of Safety
Observation
|
OnabotulinumtoxinA
(OnabotA) Exhibits Greater Efficacy Compared with Purified
Botulinum Neurotoxin A (BoNT/A-150 kDa) in Peripheral Pain Models
|
Greater Biological
Activity of OnabotulinumtoxinA and Non-interchangeability with
Vacuum-Dried PrabotulinumtoxinA
|
Botulax displays
lower enzymatic activity when compared to onabotulinumtoxinA in a
light chain activity assay
|
A Cell-Penetrating
Peptide (CPP) Did Not Decrease 150-kDa BoNT/A Toxin Adsorption to
Surfaces or Increase Toxin Potency or Duration in a Prototype
Formulation
|
Neutralizing Antibody
Conversion with OnabotulinumtoxinA from Global Studies Across
Multiple Indications in Nearly 30,000 Patient Records: A
Meta-Analysis
|
Engineering SNAP23
Specificity into the Highly Selective Clostridium Botulinum
Protease
|
About BOTOX®
BOTOX® (onabotulinumtoxinA) U.S. Important
Information
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 specific 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 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
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 forehead lines, crow's feet lines, and frown lines between
the eyebrows 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).
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 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® or BOTOX® Cosmetic. If this happens, do not
drive, 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. 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.
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, 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 amyotrophic lateral sclerosis (ALS) also
known as 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 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 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 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® and BOTOX®
Cosmetic 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 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
Globally, prescribing information varies; refer to the
individual country product label for complete
information.
About Allergan Aesthetics
Allergan Aesthetics, an
AbbVie company, develops, manufactures, and markets a portfolio of
leading aesthetics brands and products. Their aesthetics
portfolio includes facial injectables, body contouring, plastics,
skin care, and more. Their goal is to consistently provide
customers worldwide with innovation, education, exceptional
service, and a commitment to excellence, all with a personal touch.
www.AllerganAesthetics.com
About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those
living with neurological and psychiatric disorders is unwavering.
Every challenge in this uncharted territory makes us more
determined and drives us harder to discover and deliver solutions
for patients, care partners and clinicians. AbbVie's
Neuroscience portfolio consists of approved therapies and a robust
pipeline in neurological and psychiatric disorders, including
Alzheimer's disease, bipolar disorder and depression, major
depressive disorder, migraine, multiple sclerosis, Parkinson's
disease, spinal cord injuries, post-stroke spasticity,
schizophrenia, and stroke.
We have a strong investment in neuroscience research, with our
Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience
Discovery site in Ludwigshafen, Germany, where our research and resilience in
these challenging therapeutic areas is yielding a deeper
understanding of the pathophysiology of neurological and
psychiatric disorders, and identifying targets for potential
disease-modifying therapeutics aimed at making a difference in
people's lives. For more information, please visit
www.abbvie.com.
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 2019 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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