NORTH CHICAGO, Ill.,
Oct. 28, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that continuous 24
hours/day subcutaneous infusion of ABBV-951
(foslevodopa/foscarbidopa) was statistically superior to oral
levodopa/carbidopa in reducing motor fluctuations in patients with
advanced Parkinson's disease (PD) in a Phase 3, randomized,
double-blind, double-dummy, active-controlled study. The study met
its primary endpoint of increase from baseline in "On" time (hours)
without troublesome dyskinesia (involuntary movements) after 12
weeks based on the Parkinson's Disease Diary (PD
Diary).1 These results will be a key component of global
regulatory submissions.
The increase in "On" time at week 12 was 2.72 hours for ABBV-951
versus 0.97 hours for oral levodopa/carbidopa (LD/CD) (p=
0.0083).1 Improvements in "On" time were observed as
early as the first week and persisted throughout the 12
weeks.1 It was also observed that an improvement from
baseline in hours of average daily normalized "Off" time followed a
similar pattern in reductions versus oral LD/CD after the first
week and persisting through week 12.1 Decreases in "Off"
time after 12 weeks were 2.75 hours for ABBV-951 versus 0.96 hours
for oral LD/CD (p=0.0054).1
"Parkinson's disease is a progressive, irreversible neurological
disease with debilitating symptoms that can make daily life
challenging," said Michael Severino,
M.D., vice chairman and president, AbbVie. "We're committed to
addressing the continued needs of patients and are encouraged by
these results that highlight a potential alternative treatment
option for those affected by advanced Parkinson's disease."
"Patients need more therapeutic options to control their
symptoms and troublesome dyskinesia for this debilitating disease,"
said Jason Aldred, M.D. FAAN of
Selkirk Neurology, clinical associate professor at the University of Washington, clinical assistant
professor at Washington State
University Elson S. Floyd
College of Medicine, and a principal investigator of the
study. "These data are promising and demonstrate positive results
on a key endpoint used to assess efficacy of treatments for
patients with advanced Parkinson's."
The majority of the adverse events (AEs) reported were
non-serious and mild to moderate in severity in the ABBV-951
group.1 Incidence of serious AEs were 8% and 6% in the
ABBV-951 group and oral LD/CD group, respectively.1
There was one patient with a treatment-emergent AE leading to death
in the oral LD/CD group and none in the ABBV-951 group.1
The most common AEs reported in ≥5% in the ABBV-951 group were
infusion site AEs (erythema, pain, cellulitis, edema, bruising,
hemorrhage, nodule, induration, infection, and pruritus),
dyskinesia, "On" and "Off" phenomenon, fall, hallucinations
(including visual hallucination), balance disorder, constipation
and peripheral swelling.1 The incidence of infusion site
AEs was higher in the ABBV-951 group than in the oral LD/CD group
and most of them were non-serious, mild to moderate in severity,
resolved with or without treatment and none led to systemic
complications.1 Incidence of hallucination and psychosis
AEs was higher in the ABBV-951 group than in the oral LD/CD
group.1 These AEs were non-serious, mild to moderate in
severity. Incidence of falls and associated injuries was lower in
the ABBV-951 group compared to the oral LD/CD group.1
Adverse events led to study treatment discontinuation in 21.6% of
patients in the ABBV-951 group and 1.5% in the oral LD/CD
group.1
Full results from the Phase 3 study will be presented at a
future medical meeting or submitted for publication in a
peer-reviewed journal. ABBV-951 is an investigational therapy and
it is not approved for use. The safety and efficacy of ABBV-951
have not been evaluated by regulatory authorities.
About the Phase 3 M15-736 Study2
The Phase
3 randomized, double-blind, double-dummy, active-controlled study
compared the efficacy, safety and tolerability of ABBV-951
(foslevodopa/foscarbidopa) to oral LD/CD in advanced PD patients.
Parkinson's disease patients were provided with a home diary (the
PD Diary) to assess their motor status. The primary endpoint of
"good" time (defined as "On" time without dyskinesia plus "On" time
with non-troublesome dyskinesia), in contrast to "bad" time ("Off"
time plus "On" time with troublesome dyskinesia) is collected and
averaged over three consecutive days and normalized to a typical
16-hour waking period. Baseline values are defined as the average
of normalized "good" time collected over the three PD Diary days
before randomization. Approximately 130 adult participants with
advanced PD were enrolled in the study across 80 sites worldwide.
The study was comprised of two arms. In one arm, participants
received the ABBV-951 solution as a continuous infusion under the
skin plus oral placebo capsules for levodopa/carbidopa. In the
second arm, participants received placebo solution for ABBV-951 as
a continuous subcutaneous infusion plus oral capsules containing
levodopa/carbidopa encapsulated tablets. The treatment duration was
12 weeks. More information on the study can be found on
www.clinicaltrials.gov (NCT04380142).
About ABBV-951
ABBV-951 (foslevodopa/foscarbidopa) is
a solution of levodopa and carbidopa prodrugs for continuous
subcutaneous infusion that is being investigated for the treatment
of advanced Parkinson's disease in patients whose motor symptoms
are not controlled by oral medications.
About Parkinson's Disease
More than 10 million people worldwide are living with Parkinson's
disease,3 a progressive and chronic neurological
disorder characterized by tremor, muscle rigidity, slowness
of movement, and difficulty with balance.4 The
motor symptoms of Parkinson's disease result from the loss of
dopamine-producing brain cells and begin when approximately 60-80
percent of these cells are lost.4 Symptoms continue to
worsen slowly over the course of time.5 While there is
no known cure for the disease, there are treatments available to
help reduce symptoms.6
As Parkinson's disease progresses, patients can experience
fluctuations from an "On" state (when symptoms are generally well
controlled) to an "Off" state, during which tremor and stiffness
reappear and patients have more difficulty in moving.7
Patients can also experience dyskinesia (involuntary movements)
which can significantly hinder daily activities.7
Disease progression and fluctuating levodopa levels are responsible
for the onset of motor complications, including fluctuations and
dyskinesia, with 50 percent of patients reporting them two to five
years after initiation of treatment and approximately 80-100
percent of patients presenting with them after ten
years.8
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 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
Neuroscience Discovery sites in Cambridge, Massachusetts and 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.
References
1 AbbVie. Data on file.
2 Study Comparing Continuous Subcutaneous Infusion
Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of
Motor Fluctuations in Adult Participants With Advanced Parkinson's
Disease. ClinicalTrials.gov. 2021. Available at:
https://www.clinicaltrials.gov/ct2/show/NCT04380142?term=NCT04380142&draw=2&rank=1.
Accessed October 27, 2021.
3 Statistics. Parkinson's Foundation. Available
at: https://www.parkinson.org/Understanding-Parkinsons/Statistics#:~:text=More%20than%2010%20million%20people. Accessed October
27, 2021.
4 About Parkinson's: Parkinson's 101. The Michael J. Fox
Foundation for Parkinson's Research. Available
at: https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2. Accessed October
27, 2021.
5 Parkinson's Disease: Challenges, Progress, and
Promise. National Institute of Neurological Disorders and Stroke.
Available at:
https://www.ninds.nih.gov/Disorders/All-Disorders/Parkinsons-Disease-Challenges-Progress-and-Promise.
Accessed October 27, 2021.
6 Parkinson's Disease. National Institute on Aging.
Available at: https://www.nia.nih.gov/health/parkinsons-disease.
Accessed October 26, 2021.
7 Wearing off and motor fluctuations. European
Parkinson's Disease Association. Available at:
https://www.epda.eu.com/about-parkinsons/symptoms/motor-symptoms/wearing-off-and-motor-fluctuations/.
Accessed October 27, 2021.
8 Freitas ME, Hess CW, Fox SH. Motor Complications
of Dopaminergic Medications in Parkinson's Disease. Semin
Neurol. 2017;37(2):147-157. doi:10.1055/s-0037-1602423).
View original
content:https://www.prnewswire.com/news-releases/abbvie-announces-abbv-951-foslevodopafoscarbidopa-showed-improvement-in-controlling-motor-fluctuations-compared-to-oral-levodopacarbidopa-medication-in-pivotal-phase-3-trial-in-patients-with-advanced-parkinsons-disease-301410482.html
SOURCE AbbVie