NORTH CHICAGO, Ill.,
Sept. 10, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that data from its
robust neuroscience portfolio will be presented at the
International Parkinson and Movement Disorder Society (MDS) Virtual
Congress 2021, taking place September
17-22. More than 20 abstracts across disease states,
including Parkinson's disease, spasticity and cervical dystonia,
will be presented.
"At AbbVie, we are committed to addressing the unmet needs of
people living with a wide range of movement disorders,"
said Sebastian Sorsaburu, MD, vice president, global specialty
care medical affairs, AbbVie. "Our research presented at MDS 2021
builds upon our expertise in neuroscience and reinforces our
mission to advance the standards of care for people living with
these debilitating diseases."
Researchers will present results from several studies in
advanced Parkinson's disease, including long-term, real-world
data for DUODOPA® (levodopa-carbidopa intestinal gel),
as well as additional data on the long-term, real-world use of
BOTOX® (onabotulinumtoxinA) in patients with
spasticity and cervical dystonia.
Key AbbVie abstracts for the MDS Virtual Congress 2021, which
will all be available as virtual e-posters beginning at
8:00 a.m. CDT on September 10, are outlined below.
Key AbbVie
Abstracts at MDS 2021
|
Abstract
Title
|
DUODOPA® Abstracts
|
Dyskinesia, Pain, and
Quality of Life in Parkinson's Disease: Post Hoc Analysis from the
DYSCOVER Study
|
Effects of
Levodopa-Carbidopa Intestinal Gel on Dyskinesia and Non-Motor
Symptoms Including Sleep: Results from a Meta-Analysis with
24-Month Follow-Up
|
Registry Analysis (In
Progress) to Evaluate Clinical Outcomes and Disease Burden of
Advanced PD in Patients with Motor Fluctuations and Dyskinesia
Managed with Oral Dopaminergic Therapies Versus Device-Aided
Therapies
|
Impact on Dyskinesia
in Advanced Parkinson's Disease Patients Treated with LCIG:
Analysis from the COSMOS Study
|
Comparative
Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep
Brain Stimulation on Pill Burden Reduction in Medicare Patients
with Advanced Parkinson's Disease
|
Long-Term Real-World
Effectiveness of Carbidopa/Levodopa Enteral Suspension After 36
Months of Treatment Initiation: Final Results from PROviDE
Study
|
Levodopa/Carbidopa
Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On
Without Troublesome Dyskinesia in Advanced Parkinson's Disease:
Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial
|
Real-World
Characteristics of Advanced Parkinson's Disease Patients Initiating
Carbidopa/Levodopa Enteral Suspension
|
Impact of
Device-Aided Therapies on QoL and Off-Time Improvement in Advanced
Parkinson's Disease Patients: Comparative Effectiveness Results
from a Bayesian Network Meta-Analysis
|
Overview of the
Population of Patients with Advanced Parkinson's Disease (aPD)
Initiating Therapy with Levodopa-Carbidopa Intestinal Gel (LCIG):
POMPE-PARK Study on French Health Insurance Data
(2013-2017)
|
BOTOX®
Abstracts
|
OnabotulinumtoxinA
Treatment in Patients with Upper Limb and Lower Limb Spasticity
from the ASPIRE Study
|
Neutralizing Antibody
Conversion with OnabotulinumtoxinA from Global Studies Across
Multiple Indications with a Focus on Movement Disorders: A
Meta-Analysis
|
Benefits of Treatment
with OnabotulinumtoxinA in Naive and Non-Naive Patients with
Cervical Dystonia are Sustained Over Time: Preliminary Completer
Analysis from CD PROBE
|
Impact of Disease
Severity on Presentation Subtype and OnabotulinumtoxinA Utilization
in Patients with Cervical Dystonia: Results from the CD PROBE
Completer Population
|
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
|
OnabotulinumtoxinA
Exhibits Greater Efficacy Compared to Purified Botulinum Neurotoxin
A (Bont/A-150 KDA) in Peripheral Pain Models
|
Disease State
Abstracts
|
Classification of
Advanced Parkinson's Disease in OBSERVE-PD Patients Based on the
MANAGE-PD Screening Tool
|
COVID-19 Pandemic
Impact on Advanced Parkinson's Disease in the US
|
Current Perspectives
on the Management of Cervical Dystonia Among Global
Clinicians
|
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.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
DUODOPA® (levodopa/carbidopa intestinal gel) EU
Indication
DUODOPA® is indicated for the treatment of advanced
levodopa-responsive Parkinson's disease with severe motor
fluctuations and hyperkinesia or dyskinesia when available
combinations of Parkinson's medicinal products have not given
satisfactory results.
Important DUODOPA® EU Safety Information
Duodopa is contraindicated in patients with hypersensitivity to
levodopa, carbidopa or any of the excipients, narrow-angle
glaucoma, severe heart failure, severe cardiac arrhythmia, acute
stroke, selective type A inhibitors and nonselective MAO
inhibitors, conditions contraindicated for adrenergics (e.g.
pheochromocytoma, hyperthyroidism, and Cushing's syndrome), and
suspicious skin lesions or history of melanoma.
Some warnings and precautions include the following: Device and
Procedure-related complications, sudden onset of sleep: caution
should be exercised when driving and operating machines. Caution
in: severe cardiovascular or pulmonary disease, bronchial asthma,
renal, hepatic or endocrine disease, or history of peptic ulcer
disease or of convulsions. Risk of symptoms resembling Neuroleptic
Malignant Syndrome following abrupt dose reduction or
discontinuation. Monitor all patients for the development of mental
changes, depression with suicidal tendencies, and other serious
mental changes. Caution in chronic wide-angle glaucoma; monitor for
intra-ocular pressure changes. Patients with past or current
psychosis should be treated with caution. Monitor patients
regularly for the development of impulse control disorders, for
example Dopamine Dysregulation Syndrome (DDS). Polyneuropathy has
been reported; evaluate for history/signs of and known risk factors
before starting therapy. Periodic evaluation of hepatic,
haematopoietic, cardiovascular and renal function is recommended
during extended therapy with Duodopa. Some reported complications
include, but are not limited to, abscess, pneumonia (including
aspiration pneumonia), and sepsis. Patients with Parkinson's
disease have a higher risk of developing melanoma. Monitor patients
for melanomas on a regular basis when using Duodopa. Duodopa is not
recommended during pregnancy. Breast-feeding should be discontinued
during treatment with Duodopa.
The most common adverse reaction was complication of device
insertion.
The very common (≥ 10%) and common (≥1% to < 10%)
device and procedure -related adverse reactions reported in the
clinical trials included in clinical trials
included: Abdominal discomfort, Abdominal pain, Peritonitis,
Pneumoperitoneum Postoperative wound infection, incisional
cellulitis, pneumonia/aspiration pneumonia, excessive granulation
tissue, device dislocation, device occlusion, complications of
device insertion, incision site erythema, post-procedural
discharge, stoma complication, incision site pain, Postoperative
Ileus, Post procedural complication, Post procedural discomfort,
post procedural haemorrhage.
Most of these adverse reactions were reported early in the
studies, subsequent to the percutaneous endoscopic gastrostomy
procedure and occurred during the first 28 days.
Drug related undesirable effects that occur frequently with the
Duodopa system include nausea and dyskinesia.
This is not a complete summary of all safety
information.
See DUODOPA® full summary of product
characteristics (SmPC) at
https://www.medicines.org.uk/emc/. Globally, prescribing
information varies; refer to the individual country product label
for complete information.
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 I disorder,
major depressive disorder, migraine, Parkinson's
disease, spinal cord injuries, post-stroke spasticity,
schizophrenia, stroke and others.
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.
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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