– Data analyses of onabotulinumtoxinA
(BOTOX®) in adult patients with chronic
migraine, cervical dystonia, overactive bladder, spasticity, and
pediatric patients with neurogenic detrusor overactivity provide
further insights on real-world utilization and long-term
use
– Study results on onabotulinumtoxinA (BOTOX®
Cosmetic) in moderate to severe forehead lines, lateral canthal
lines, and glabellar lines to be presented
– Company to share advances in aesthetic medicine, including
investigational results from a Phase 2b study in patients with masseter muscle
hypertrophy
NORTH
CHICAGO, Ill., July 25,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Allergan
Aesthetics announced today that more than 30 abstracts, including
seven podium presentations, will be presented during the upcoming
TOXINS 2022 Conference, July 27-30 in
New Orleans. Clinical studies,
health economics, preclinical research, and real-world utilization
data will highlight onabotulinumtoxinA (BOTOX® and
BOTOX® Cosmetic) across approved and investigational
indications.
"For more than 32 years, we have remained committed to advancing
neurotoxin science to better address the unmet needs of patients
across a variety of conditions and our work continues," said
Mitchell F. Brin, M.D., senior vice president, chief
scientific officer, BOTOX® & Neurotoxins, AbbVie.
"Our data at TOXINS reinforce not only our leadership in neurotoxin
research and development, but also our commitment to provide
world-class medical education to help accelerate scientific
knowledge and technical skills that can help improve patient
outcomes."
At the meeting, researchers will present data on the use of
onabotulinumtoxinA in chronic migraine, pediatric neurogenic
detrusor overactivity, overactive bladder, cervical dystonia, and
spasticity. Notable data will include an analysis from the CD-PROBE
study, which evaluated the safety and efficacy of
onabotulinumtoxinA in difficult-to-treat cervical dystonia
postures: anterocollis and retrocollis.
Additionally, the company will share advances in aesthetic
medicine, including new data on onabotulinumtoxinA in moderate to
severe forehead lines, lateral canthal lines, and glabellar lines.
Investigational results will also be presented from a phase
2b study of onabotulinumtoxinA in
patients with masseter muscle hypertrophy.
"Our deep scientific focus continues to drive exciting
innovations in aesthetic medicine," said Darin Messina, senior vice president, global
head of aesthetics R&D, AbbVie. "We look forward to presenting
results from our phase 2 dose-escalation study of
onabotulinumtoxinA in masseter muscle prominence, a known area of
aesthetic concern for a growing number of patients."
Key abstracts and presentation details for the TOXINS 2022
conference are outlined below.
Abstract
Title
|
Presentation
Details
All Times
EDT
|
Chronic
Migraine
|
Real-World Safety and
Efficacy of 155-195U OnabotulinumtoxinA in Participants With
Chronic Migraine: Results From the REPOSE Study
|
Podium
presentation
Friday, July
29
3:05 – 3:15
PM
|
Real-World Evidence for
the Safety and Efficacy of CGRP Monoclonal Antibody Therapy Added
to OnabotulinumtoxinA Treatment for Migraine Prevention in Adult
Patients with Chronic Migraine
|
Podium
presentation
Friday, July
29
3:15 – 3:25
PM
|
Consecutive
Headache-Free Days With OnabotulinumtoxinA Treatment in Patients
With Chronic Migraine: A Pooled PREEMPT Analysis
|
Podium
presentation
Friday, July
29
3:25 – 3:35
PM
|
Real-World Persistence
and Costs Among Patients With Chronic Migraine Treated With
OnabotulinumtoxinA or CGRP mAbs: A Retrospective Claims Analysis
Study
|
Poster
|
Real-World
Effectiveness of Ubrogepant for the Acute Treatment of Migraine in
Combination with OnabotulinumtoxinA Preventive: Results From the
COURAGE Study
|
Poster
|
PREDICT: PREEMPT
Fixed-Dose, Fixed-Site, and Follow the Pain
|
Poster
|
Preclinical Assessment
of OnabotulinumtoxinA for The Treatment of Mild Traumatic Brain
Injury–Related Acute and Persistent Cephalic Allodynia
|
Poster
|
Cervical
Dystonia
|
Current perspectives on
the management of cervical dystonia among global
clinicians
|
Podium
presentation
Thursday, July
28
5:10 – 5:20
PM
|
Impact of Disease
Severity on Presentation Subtype and OnabotulinumtoxinA Utilization
in Patients with Cervical Dystonia: Results from the CD PROBE
Completer Population
|
Poster
|
Real-world botulinum
toxin type A treatment patterns in patients with cervical
dystonia
|
Poster
|
Characteristics and
Treatment Response to OnabotulinumtoxinA of Patients From CD-PROBE
With Anterocollis and Retrocollis
|
Poster
|
Urology
|
OnabotulinumtoxinA,
Nerve Stimulation Devices, Mirabegron, and Anticholinergics versus
Best Supportive Care for Overactive Bladder: An Updated US Cost
Effectiveness Analysis
|
Poster
|
OnabotulinumtoxinA is
efficacious and well tolerated in male patients with overactive
bladder and urinary incontinence: placebo-controlled treatment
cycle 1 results from a pooled analysis of four randomized
trials
|
Poster
|
Long-term Safety and
Tolerability of Repeated Treatments with OnabotulinumtoxinA in
Children with Neurogenic Detrusor Overactivity
|
Poster
|
OnabotulinumtoxinA
Improves Idiopathic Overactive Bladder Symptoms in Patients
Refractory to Oral Medications
|
Poster
|
Spasticity
|
A Virtual Reality
Platform to Facilitate Training on Treatment of Lower Limb
Spasticity With OnabotulinumtoxinA
|
Poster
|
Dosing, treatment
intervals, and treatment satisfaction with onabotulinumtoxinA over
time in the Adult Spasticity International Registry
(ASPIRE)
|
Poster
|
Real-World Treatment
Utilization and Effectiveness of OnabotulinumtoxinA in Multiple
Sclerosis Patients Treated for Spasticity from the ASPIRE
Study
|
Poster
|
Treatment of patients
with upper limb and lower limb spasticity with onabotulinumtoxinA
in the Adult Spasticity International Registry (ASPIRE)
|
Poster
|
Content Validation of a
Post-stroke Spasticity Risk Classification System: Cognitive
Interviews with Clinicians
|
Poster
|
Healthcare Resource
Utilization and Costs Among Patients With Stroke-related Spasticity
Before and After Treatment With OnabotulinumtoxinA
|
Poster
|
Real-world botulinum
toxin type A treatment patterns in patients with
spasticity
|
Poster
|
Real-World Dosing
Differences of OnabotulinumtoxinA and AbobotulinumtoxinA in
Treatment of Upper Limb Spasticity
|
Poster
|
Individualized
OnabotulinumtoxinA Treatment of Upper Limb Spasticity in US
Clinical Practices: Analysis of Practice Patterns From the ASPIRE
Study
|
Poster
|
Aesthetics
|
Safety and Efficacy of
OnabotulinumtoxinA for Treatment of Masseter Muscle Hypertrophy:
Results from a Phase 2B Study
|
Podium
presentation
Thursday, July
28
3:10 pm - 3:25
pm
|
OnabotulinumtoxinA for
Treatment of Masseter Muscle Prominence: Secondary Results from a
Phase 2 Dose-Escalation Study
|
Podium
presentation
Thursday, July
28
3:10 – 3:25
PM
|
Efficacy and Safety of
Two Doses of OnabotulinumtoxinA for the Treatment of Masseter
Muscle Prominence: Six-Month Results From a Randomized, Phase 2b
Placebo-Controlled Study
|
Poster
|
Masseter Prominence
Reduction, Treatment Satisfaction, and Self-Perceived Lower Face
Appearance After OnabotulinumtoxinA: Results From a Randomized,
Controlled, Phase 2b Trial
|
Poster
|
Treatment of Upper
Facial Lines With OnabotulinumtoxinA Results in Long-Lasting
Efficacy and Patient Satisfaction
|
Poster
|
Toxin
Science/General Neurotoxins
|
Botulinum Neurotoxin
Accelerates the Resolution of Bacterial Skin Infections in
Mice
|
Podium
presentation
Friday, July
29
5:15 – 5:25
PM
|
Botulinum Neurotoxin
Type A Directly Affects Sebocytes and Modulates Oleic Acid-Induced
Lipogenesis
|
Poster
|
In addition to posters being displayed at the TOXINS 2022
conference, there will also be a virtual poster hall on the
International Neurotoxin Association website here where posters
will be available for viewing by conference attendees for six
months after the conference. The full TOXINS 2022 conference
program can be found here.
About BOTOX®
BOTOX® (onabotulinumtoxinA) U.S.
Important Information
IMPORTANT SAFETY INFORMATION
BOTOX® (onabotulinumtoxinA) 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
preexisting 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; 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 (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 due to a neurologic disease when
another type of medicine (anticholinergic) does not work well
enough or cannot be taken
- 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 and 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.
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 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 and BOTOX Cosmetic are safe and
effective for severe sweating anywhere other than your armpits.
It is not known if BOTOX Cosmetic is safe and 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 receiving BOTOX or 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 (difficulty
fully emptying the bladder), only patients who are willing and able
to initiate catheterization posttreatment, 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 postinjection
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 adult 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 postinjection 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 adult patients not using CIC at baseline, those with MS
were more likely to require CIC postinjection 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 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 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 a 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; have weakness of forehead
muscles, trouble raising your eyebrows, drooping eyelids, and any
other abnormal facial change; have symptoms of a UTI and are being
treated for urinary incontinence (symptoms of a UTI 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 such as double vision, blurred
vision, decreased eyesight, drooping eyelids, swelling of your
eyelids, and dry eyes; drooping eyebrows; and upper respiratory
tract infection. In adults being treated for urinary incontinence,
other side effects include UTI and painful urination. In children
being treated for urinary incontinence, other side effects include
UTI and bacteria in the urine. In patients being treated for
urinary incontinence, another side effect includes the inability to
empty your bladder on your own. 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.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.
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 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
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 2021 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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SOURCE AbbVie