NORTH CHICAGO, Ill.,
Sept. 23, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced experts in the
neuroscience field will present results from two late-breaking
abstracts, including final data from the Phase 1b study evaluating the safety and tolerability
of the investigational medicine ABBV-951 in patients with advanced
Parkinson's disease (PD), and data from the real-world DUOGLOBE
study, evaluating the effect of DUODOPA® (levodopa/carbidopa
intestinal gel) in patients with advanced Parkinson's disease. In
total, 22 abstracts featuring new and updated data evaluating
AbbVie's neuroscience portfolio and pipeline will be presented at
the 2019 International Congress of Parkinson's Disease and Movement
Disorders®, September 22-26 in
Nice, France.
The Phase 1b study evaluating
ABBV-951 was designed to determine the safety and tolerability of
ABBV-951, an investigational solution of levodopa/carbidopa
delivered through continuous subcutaneous infusion (CSCI) in
patients with advanced Parkinson's disease. A Phase 3 study
evaluating the safety and tolerability of ABBV-951 (NCT-03781167)
CSCI over 24 hours per day is currently enrolling patients. The
design of the Phase 3 study will be presented as a poster at the
congress.
The multinational, real-world observational study, DUOGLOBE, was
designed to evaluate the effect of DUODOPA on motor symptoms/motor
complications (including "off" time and dyskinesia), quality of
life (QoL) and caregiver burden, in patients with advanced PD who
were treated with DUODOPA in routine clinical practice. 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 medicinal
products have not given satisfactory results.
"Our research presented at the congress demonstrates our
longstanding commitment to developing and delivering science that
will make a difference in the lives of people with Parkinson's
disease and other neurodegenerative conditions," said Michael Gold, M.D., vice president, neuroscience
development, AbbVie. "We are excited to share this latest data with
leading researchers around the world as we take a few steps closer
to potentially providing patients with much needed additional
treatment options."
Other data presentations include the pharmacokinetics of
ABBV-951, the impact of progressive supranuclear palsy (PSP) on
healthcare resource utilization and PSP caregivers, and several
studies examining DUODOPA in advanced PD patients in a variety of
clinical and real-world settings, including its impact on motor
symptoms when using wearable sensors, its utilization in patients
being treated with add-on therapies, and in patients with non-motor
symptoms. Abstracts demonstrating the prevalence, impact and burden
of PD will also be presented.
About Parkinson's Disease
More than 6 million
people worldwide are living with Parkinson's disease, a progressive
and chronic movement disorder1 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.1 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.3 While there is no known
cure for the disease, there are treatments available to help reduce
symptoms.3
As Parkinson's disease progresses, patients may experience
fluctuations from an "on" state to an "off state," during
which they are slower, stiffer and experience more difficulty
moving. Patients may also experience dyskinesias (involuntary
movements).
About Progressive Supranuclear
Palsy
Progressive supranuclear palsy (also known as
Steele-Richardson-Olszewski syndrome) is a progressive
neurodegenerative disorder, with an estimated worldwide annual
prevalence of three to six per 100,000 people.4 The
average onset of PSP symptoms typically begins after age 60. The
most common features of PSP are loss of balance leading to
unexplained falls, blurred vision, problems controlling eye
movement and slurred speech. Other nonspecific symptoms of PSP,
such as slowed movements or behavioral or cognitive changes, are
similar to other brain disorders, particularly Parkinson's disease.
For this reason, correct diagnosis of PSP is often delayed. The
course of PSP is progressive and may predispose individuals to
serious complications, such as choking, pneumonia, head injury and
fractures caused by falls. Currently, there are no approved
treatments for PSP.4
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 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, 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
www.ema.europa.eu. Globally, prescribing information
varies; refer to the individual country product label for complete
information.
About ABBV-951
ABBV-951 is an investigational
levodopa/carbidopa prodrug delivered subcutaneously being studied
for the treatment of advanced Parkinson's disease.
About AbbVie in Neuroscience
At AbbVie, our
commitment to addressing the needs of people living with
neurodegenerative disease is unwavering. Every challenge in this
uncharted territory makes us more determined and drives us harder
to discover and deliver solutions for patients, caregivers and
clinicians. AbbVie's Neuroscience portfolio consists of approved
therapies and a robust pipeline in neurodegenerative diseases,
including Alzheimer's disease, Parkinson's disease and multiple
sclerosis. 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 is yielding a
deeper understanding of the pathophysiology of neurodegenerative
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 is a global, research and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, LinkedIn or Instagram.
1 The Michael J. Fox Foundation for Parkinson's
Research.
https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2
Accessed August 16, 2019.
2 The Michael J. Fox Foundation for Parkinson's
Research.
https://www.michaeljfox.org/understanding-parkinsons/living-with-pd/topic.php?symptoms.
Accessed August 16, 2019.
3 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 16, 2019.
4 National Institute of Neurological Disorders and
Strokes. Progressive Supranuclear Palsy Fact
Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Progressive-Supranuclear-Palsy-Fact-Sheet.
Accessed August 16, 2019.
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