--Results will be presented from the Phase 3 M15-736 trial, a
randomized, double-blind, double-dummy, active-controlled study,
evaluating the continuous subcutaneous infusion of ABBV-951
(foslevodopa/foscarbidopa) in people with advanced Parkinson's
disease
--Data will also be presented on real-world
efficacy of BOTOX® (onabotulinumtoxinA) for the
treatment of spasticity and BOTOX® for the treatment of
cervical dystonia
--Research highlights AbbVie's
continued commitment to advancing the management of movement
disorders
NORTH
CHICAGO, Ill., Sept. 15,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that data from its robust neuroscience portfolio
will be presented at the 2022 International Parkinson and Movement
Disorder Society's (MDS) International Congress, taking place in
Madrid, Spain, from September 15-18. A total of 13 abstracts will be
presented across multiple disease states, including Parkinson's
disease, spasticity and cervical dystonia.
"At AbbVie, we understand the realities and challenges that
people living with movement disorders face and are relentless in
our pursuit to address the unmet needs," said Mudra Kapoor,
M.D., vice president, neuroscience, global medical affairs, AbbVie.
"Our research presented at this year's MDS International Congress
reinforces our expertise in neuroscience and builds upon our
mission to advance treatment for people living with these
debilitating diseases."
At MDS, researchers will present results from M15-736, a
randomized, double-blind, double-dummy, active-controlled Phase 3
study, evaluating the continuous subcutaneous infusion of ABBV-951
(foslevodopa/foscarbidopa) in people with advanced Parkinson's
disease, as well as real-world data from the ASPIRE study,
evaluating BOTOX® for the treatment of spasticity. The
data will be presented during the guided poster tours.
AbbVie will also host a medical symposium on Thursday, September 15, from 13:30-14:30 Central
European Summer Time (CEST) titled "Transforming care towards a
patient-centered approach to early identification of suboptimal PD
control," featuring physicians who will discuss the rationale for
improving care in Parkinson's disease patients whose symptoms
remain uncontrolled on oral medications.
AbbVie abstracts presented at the 2022 MDS International
Congress are outlined below.
Key AbbVie Abstracts
at 2022 MDS International Congress
|
Abstract
Title
|
Abstract
Details
|
Advanced Parkinson's
Disease
|
Subcutaneous
Foslevodopa/Foscarbidopa in Patients with Advanced Parkinson's
Disease: Results from a Randomized,
Double-Blind, Double-Dummy Phase 3 Trial
|
Friday, September
16
13:00-15:00
CEST
Guided Poster
Tour
|
Impact of
Foslevodopa/Foscarbidopa on Key Clinical and Patient-Reported
Outcomes in Patients with aPD: Responder
Analysis of Two Phase 3 Clinical Trials
|
Friday, September
16
14:00-14:30 CEST
|
Concomitant Medication
Use and Levodopa Equivalent Daily Dose Requirements After
Foslevodopa/foscarbidopa Initiation
|
Friday, September
16
13:00-15:00 CEST
Guided Poster
Tour
|
Rapid Onset of Good ON
Time and Improvement in Motor-State Stability in aPD Patients After
Treatment with Continuous
Subcutaneous Foslevodopa/Foscarbidopa
|
Friday, September
16
13:00-15:00 CEST
Guided Poster
Tour
|
Patient and Caregiver
Satisfaction of Video-Assisted Telenursing in Patients Treated with
Levodopa/Carbidopa Intestinal
Gel (LCIG)
|
Thursday, September
15
14:00-14:30 CEST
|
Clinical Outcomes and
Disease Burden of Advanced Parkinson's Disease Patients Treated
with Oral Medication Vs.
Device-Aided Therapies: Preliminary Results from the University of
Florida Registry Analysis
|
Saturday, September
17
13:00-13:30 CEST
|
Reported Clinical and
Quality-of-Life Outcomes with 24-Hour Levodopa-Compared with
16-Hour Administration
|
Saturday, September
17
13:00-13:30 CEST
|
Spasticity
|
Pain and Disability
Outcomes in Hemiparetic Patients Naive to Botulinum Toxins with
Upper and Lower Limb Spasticity Treated
with OnabotulinumtoxinA: Insights from the ASPIRE Study
|
Friday, September
16
13:00-13:30 CEST
|
Treating Upper Limb
Spasticity with OnabotulinumtoxinA: Subgroup Analysis of US
Practice Patterns from the ASPIRE Study
|
Friday, September
16
14:00-14:30 CEST
Guided Poster
Tour
|
Real-World Clinical
Utilization Differences of OnabotulinumtoxinA and
AbobotulinumtoxinA in Upper Limb Spasticity
|
Friday, September
16
14:30-15:00 CEST
|
Pain and Disability
Outcomes in Hemiparetic Patients with Post-Stroke Spasticity:
Exploratory Analysis of the ASPIRE Study
|
Friday, September
16
14:30-15:00 CEST
|
Cervical
Dystonia
|
Characteristics and
Treatment Response to OnabotulinumtoxinA of Patients from CD-PROBE
with Retrocollis Subtype of
Cervical Dystonia
|
Friday, September
16
13:00-13:30 CEST
|
Characteristics and
Treatment Response to OnabotulinumtoxinA of Patients from CD-PROBE
with Anterocollis Subtype of
Cervical Dystonia
|
Friday, September
16
13:00-13:30 CEST
|
The 2022 MDS International Congress is a hybrid meeting taking
place in-person and virtually. The virtual platform features
on-demand recordings of scientific sessions, a poster hall, and an
exhibition hall, all of which will become available after the
in-person congress concludes. The full 2022 MDS International
Congress program can be found here.
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
and in pediatric patients five years of age and older, cervical
dystonia, adult and pediatric spasticity, and severe underarm
sweating (axillary hyperhidrosis). Botulinum toxin units are not
interchangeable from one product to another; doses recommended in
Allergan Units are different from other botulinum toxin
preparations.
U.S. Indications and Important Safety Information about
BOTOX® (onabotulinumtoxinA)
INDICATIONS
BOTOX® (onabotulinumtoxinA) 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.
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
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, or strabismus.
BOTOX may cause loss of strength or general muscle weakness,
vision problems, or dizziness within hours to weeks of receiving
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 (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 a
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
multiple sclerosis were more likely to require CIC postinjection
than those with spinal cord injury.
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 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 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 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.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
U.S. Indication and Important Safety Information About
DUOPA® (levodopa/carbidopa)
DUOPA (carbidopa and levodopa) enteral suspension is indicated
for the treatment of motor fluctuations in patients with advanced
Parkinson's disease.
What is the most important safety information I should know
about DUOPA?
- Stomach and intestine (gastrointestinal) problems and
problems from the procedure you will need to have to receive DUOPA
(gastrointestinal procedure-related problems) may occur. Some
of these problems may require surgery and may lead to death.
-
- Serious side effects may include: a blockage of your
stomach or intestines (bezoar); stopping movement through
intestines (ileus); drainage, redness, swelling, pain, feeling of
warmth around the small hole in your stomach wall (stoma); bleeding
from stomach ulcers or your intestines; inflammation of your
pancreas (pancreatitis); infection in your lungs (pneumonia); air
or gas in your abdominal cavity; skin infection around the
intestinal tube, pocket of infection (abscess), or infection in
your blood (sepsis) or abdominal cavity may occur after surgery;
stomach pain, nausea, or vomiting.
- Tell your healthcare provider right away if you have any of the
following symptoms of stomach and intestine problems and
gastrointestinal procedure-related problems: stomach (abdominal)
pain; constipation that does not go away; nausea or vomiting;
fever; blood in your stool; or a dark tarry stool.
Your healthcare provider will talk to you about the stoma
procedure. Before the stoma procedure, tell your healthcare
provider if you ever had a surgery or problems with your
stomach.
Talk to your healthcare provider about what you need to do to
care for your stoma. After the procedure, you and your
healthcare provider will need to regularly check the stoma for any
signs of infection.
Do not take DUOPA if you currently take or have recently
taken (within 2 weeks) a medication for depression called a
non-selective monoamine oxidase (MAO) inhibitor. Ask your
healthcare provider or pharmacist if you are not sure if you take
an MAO inhibitor.
Tell your healthcare provider about all the
medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
Using DUOPA with certain other medicines, including medications for
high blood pressure, MAO inhibitors, antipsychotics,
metoclopramide, isoniazid, and iron or vitamin supplements, may
cause serious side effects. High-protein foods may affect how DUOPA
works. Tell your healthcare provider if you change your diet.
DUOPA may cause serious side effects. Talk to your doctor
before starting DUOPA and while on DUOPA if you have had or have
any of these:
- Falling asleep during normal daily activities without
warning. DUOPA may cause you to fall asleep while you are doing
daily activities such as driving, which may result in an accident.
This can happen as late as one year after starting DUOPA. Do
not drive or operate machinery until you know how DUOPA affects
you. Tell your healthcare provider if you take medicines that can
make you sleepy, such as sleep medicines, antidepressants, or
antipsychotics.
- Low blood pressure when you stand or sit up
quickly. After you have been sitting or lying down, stand up
slowly to help reduce dizziness, nausea, sweating, or fainting
until you know how DUOPA affects you.
- Seeing, hearing, or feeling things that are not real
(hallucinations).
- Unusual urges. Some people taking medicines for
Parkinson's disease, including DUOPA, have reported urges such as
excessive gambling, compulsive eating, compulsive shopping, and
increased sex drive.
- Depression and suicide. DUOPA can cause or worsen
depression. Pay close attention to changes in your mood, behavior,
thoughts, or feelings. Call your healthcare provider right away if
you feel depressed or have thoughts of suicide.
- Uncontrolled sudden movements (dyskinesia). If you have
new dyskinesia or your dyskinesia gets worse, tell your healthcare
provider. This may be a sign that your dose of DUOPA or other
Parkinson's medicines may need to be adjusted.
- Progressive weakness or numbness or loss of sensation
in the fingers or feet (neuropathy).
- Heart attack or other heart problems. Tell your
healthcare provider if you have experienced increased blood
pressure, a fast or irregular heartbeat, or chest pain.
- Abnormal blood tests. DUOPA may cause changes in certain
blood tests, especially certain hormone and kidney function blood
tests.
- Worsening of the increased pressure in your eyes
(glaucoma). The pressure in your eyes should be checked after
starting DUOPA.
Do not stop using DUOPA or change your dose unless you are
told to do so by your healthcare provider. Tell your healthcare
provider if you develop withdrawal symptoms such as fever,
confusion, or severe muscle stiffness.
The most common side effects of DUOPA include:
complications of tubing placement procedure, swelling of legs and
feet, nausea, high blood pressure (hypertension), depression, and
mouth and throat pain.
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 the full Prescribing Information including
Medication Guide for additional information about DUOPA. Talk to
your healthcare provider if you have questions.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About ABBV-951
ABBV-951 is an investigational subcutaneous delivery of
levodopa/carbidopa being evaluated for the treatment of advanced
levodopa-responsive Parkinson's disease with severe motor
fluctuations and hyperkinesia or dyskinesia when available
combinations of Parkinson medicinal products have not given
satisfactory results. ABBV-951 is an investigational therapy
and it is not approved for use.
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 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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