NORTH CHICAGO, Ill.,
Sept. 11, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced it will present results from several
studies, including the DYSCOVER study evaluating the efficacy of
DUODOPA® (levodopa/carbidopa intestinal gel) on the duration and
severity of dyskinesia in patients with advanced Parkinson's
disease (PD), at the 2020 International Congress of Parkinson's
Disease and Movement Disorders® Virtual Congress, September 12-16. In total, 18 abstracts will be
presented, including an overview of the pivotal Phase 3 study
design for the investigational medicine ABBV-951 in patients with
advanced PD, several studies evaluating the economic burden of PD,
as well new and updated data evaluating AbbVie's neuroscience
portfolio and pipeline.
The 12-week DYSCOVER study is the first randomized clinical
trial comparing the efficacy of DUODOPA to optimized medical
treatment (OMT) on dyskinesia in advanced PD patients using the
Unified Dyskinesia Rating Scale (UDysRS), which measures all
aspects of dyskinesia with a comprehensive score as the primary
endpoint.
The study design for the multi-country, open-label, single arm,
52-week pivotal phase 3 study of ABBV-951
(foscarbidopa/foslevodopa), a subcutaneous delivery of
levodopa/carbidopa being investigated for the treatment of advanced
PD, will also be presented. The study is evaluating the local and
systemic safety and tolerability of ABBV-951 delivered as a
continuous, all-day subcutaneous infusion via an external pump for
up to 52 weeks in people with advanced PD. The study is in process
and estimated to conclude in late 2021.
"At AbbVie, we are resolute in our commitment to address the
unmet needs of people living with neurologic diseases through new
and innovative solutions," said Michael
Gold, MD, Vice President, Neuroscience Development. "In the
face of uncertainty and the unknown, we are determined to preserve
personhood. We look forward to participating in the MDS 2020
Virtual Congress and sharing our latest research with scientists
and healthcare professionals from around the globe."
Other data presentations include analyses from several
DUODOPA-related studies, including the COSMOS Observational Study,
a multi-country, cross-sectional, retrospective, post-marketing
observational study that enrolled patients with advanced PD who
were treated with DUODOPA for more than 12 months. Also being
presented are analyses from the DUOGLOBE study, a three-year
global, multicenter, single-arm, non-interventional post-marketing
observational study of patients with advanced PD treated with
DUODOPA.
Additionally, abstracts demonstrating the prevalence, impact and
economic burden of PD will be presented.
About Parkinson's Disease
More than 10 million
people worldwide are living with Parkinson's disease1, a
progressive and chronic movement disorder characterized by
tremor, muscle rigidity, slowness of movement and difficulty with
balance.2 It is classified as a movement disorder
resulting from the loss of dopamine-producing brain
cells.3 The motor symptoms of Parkinson's disease
begin when approximately 60-80 percent of the dopamine-producing
cells in the brain are lost and symptoms continue to worsen slowly
over the course of time.4 While there is no known
cure for the disease, there are treatments available to help reduce
symptoms.5
As Parkinson's disease progresses, patients can experience
fluctuations from an "on state" to an "off state," during
which they are slower and stiffer and experience more difficulty
moving. Patients can also experience dyskinesias (involuntary
movements). Dyskinesia is among the most troublesome symptoms of
the disease with approximately 50 percent of patients presenting
with dyskinesia four to five years after initiation of treatment
and approximately 90 percent of patients presenting with dyskinesia
after nine years.6
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). Periodic evaluation
of hepatic, haematopoietic, cardiovascular and renal function is
recommended during extended therapy with DUODOPA. 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 clinical
trials included abdominal discomfort, abdominal pain,
peritonitis, pneumoperitoneum postoperative wound infection,
incisional cellulitis, 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 and
post-procedural hemorrhage.
Most of these adverse reactions were reported early in the
studies, subsequent to the percutaneous endoscopic gastrostomy
procedure, occurring 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
www.ema.europa.eu. Globally, prescribing information
varies; refer to the individual country product label for complete
information.
About ABBV-951
ABBV-951 is a subcutaneous delivery of
levodopa/carbidopa being investigated for the treatment of advanced
Parkinson's disease.
About AbbVie in Neuroscience
At AbbVie, our
commitment to preserve the personhood of those living with
neurologic 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 neurologic and
psychiatric disorders, including Alzheimer's disease, bipolar
disorder and depression, major depressive disorder, migraine,
multiple sclerosis, Parkinson's disease, 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
perseverance in these challenging therapeutic areas is yielding a
deeper understanding of the pathophysiology of neurologic diseases,
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.
1 Parkinson's Foundation.
https://www.parkinson.org/Understanding-Parkinsons/Statistics#:~:text=More%20than%2010%20million%20people Accessed
August 27, 2020.
2 The Michael J. Fox Foundation for Parkinson's
Research.
https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2 Accessed August
27, 2020.
3 The Michael J. Fox Foundation for Parkinson's
Research.
https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2 Accessed August
27, 2020.
4 National Institute of Neurological Disorders and
Stroke.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research.
Accessed August 27, 2020.
5 National Institute of Neurological Disorders and
Stroke.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research.
Accessed August 27, 2020.
6 Van Laar T. CNS Drugs.
2003;17:475-489.
View original
content:http://www.prnewswire.com/news-releases/abbvie-to-present-new-data-from-18-abstracts-at-the-international-congress-of-parkinsons-disease-and-movement-disorders-301128096.html
SOURCE AbbVie