Acorda to Present New Data For INBRIJA™ (levodopa inhalation powder) at 70th American Academy of Neurology Annual Meeting
April 16 2018 - 7:00AM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR) will present new data
for INBRIJA during four oral platform presentations at the upcoming
American Academy of Neurology Annual Meeting in Los Angeles, taking
place April 21–27, 2018. INBRIJA is an investigational inhaled
levodopa treatment for symptoms of OFF periods in people with
Parkinson’s disease taking a carbidopa/levodopa regimen.
“We are delighted to have the opportunity to present data from
our Phase 3 clinical development program for INBRIJA, an
investigational treatment for people with Parkinson’s living with
OFF periods, or the re-emergence of Parkinson’s symptoms. To date,
INBRIJA has been studied in more than 800 people with Parkinson’s
worldwide,” said Burkhard Blank, M.D., Acorda's Chief Medical
Officer. “OFF periods are one of the most disruptive aspects of
Parkinson’s and there is a tremendous unmet need for new treatment
options to address them.”
The INBRIJA data will be presented on Tuesday, April 24, 2018,
during Session S26: Movement Disorders - Parkinson’s Disease
Clinical Trials from 3:30 PM – 5:30 PM PT. Details are as
follows:
PRESENTATIONTIME
ABSTRACT # TITLE
PRESENTER 4:06 PM PT 3102
Inhaled Levodopa Administered With
OralCarbidopa/Levodopa for Early Morning OFFSymptoms in Patients
with Parkinson’s Disease:Exploratory Efficacy Analysis
Stuart H.Isaacson, MD
4:18 PM PT 3008
Inhaled Levodopa Administered With
OralCarbidopa/Levodopa for Early Morning OFFSymptoms in Patients
with Parkinson’s Disease:Safety Assessment
Robert A.Hauser, MD
4:30 PM PT 1484
Long-Term Pulmonary Safety of Inhaled
Levodopa inParkinson’s Disease Subjects with Motor Fluctuations:a
Phase 3 Open-Label Randomized Study
Charles Oh,MD
4:54 PM PT
1454
Long-term Efficacy of Inhaled Levodopa
inParkinson’s Disease Subjects with Motor Fluctuations:a Phase 3
Open-Label Randomized Study
Charles OH,MD
A New Drug Application for INBRIJA was accepted for review by
U.S. Food and Drug Administration in February 2018, and FDA has set
a target PDUFA date of October 5, 2018.
Acorda will also present data from the Phase 3 tozadenant
clinical trial on Monday, April 23, 2018, during Session P2:
Movement Disorders, Poster Presentation #045 between 11:30 AM and 7
PM PT.
About Parkinson’s and OFF periods
Parkinson’s is a progressive neurodegenerative disorder
resulting from the gradual loss of certain neurons responsible for
producing dopamine. Approximately one million people in the U.S.
and 1.2 million Europeans are diagnosed with Parkinson’s; OFF
periods are experienced by approximately 350,000 in the U.S. and
420,000 in Europe. It causes a range of symptoms including impaired
movement, muscle stiffness and tremors. As Parkinson’s progresses,
people will experience OFF periods, which are characterized by the
re-emergence of Parkinson’s motor and non-motor symptoms. This
re-emergence can occur even when an individual’s treatment regimen
has been optimized.
About INBRIJATM (levodopa inhalation powder)
and ARCUS®
INBRIJA is a self-administered, orally inhaled levodopa (L-dopa)
therapy in development for the treatment of symptoms of OFF periods
in people with Parkinson’s disease taking a carbidopa/levodopa
regimen. INBRIJA utilizes Acorda’s investigational ARCUS® platform
for inhaled therapeutics. INBRIJA was designed to deliver a precise
dose of a dry powder formulation of L-dopa through the lung. Oral
medication can be associated with variable onset of action, as the
medicine is absorbed through the gastrointestinal (digestive) tract
before reaching the brain. Inhaled treatments enter the body
through the lungs and reach the brain, bypassing the digestive
system.
The proprietary name INBRIJA has been conditionally accepted by
the U.S. Food and Drug Administration (FDA).
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biopharmaceutical
company focused on developing therapies that restore function and
improve the lives of people with neurological disorders. Acorda has
a pipeline of novel neurological therapies addressing a range of
disorders, including Parkinson’s disease and multiple sclerosis.
Acorda markets two FDA-approved therapies, including AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg.
Forward-Looking Statement
This press release includes forward-looking statements. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects
should be considered forward-looking. These statements are subject
to risks and uncertainties that could cause actual results to
differ materially, including: the ability to realize the benefits
anticipated from acquisitions, among other reasons because acquired
development programs are generally subject to all the risks
inherent in the drug development process and our knowledge of the
risks specifically relevant to acquired programs generally improves
over time; we may need to raise additional funds to finance our
operations and may not be able to do so on acceptable terms; our
ability to successfully market and sell Ampyra (dalfampridine)
Extended Release Tablets, 10 mg in the U.S., which will likely be
materially adversely affected by the March 2017 court decision in
our litigation against filers of Abbreviated New Drug Applications
to market generic versions of Ampyra in the U.S.; the risk of
unfavorable results from future studies of Inbrija (levodopa
inhalation powder) or from our other research and development
programs, or any other acquired or in-licensed programs; we may not
be able to complete development of, obtain regulatory approval for,
or successfully market Inbrija or any other products under
development; third party payers (including governmental agencies)
may not reimburse for the use of Ampyra, Inbrija or our other
products at acceptable rates or at all and may impose restrictive
prior authorization requirements that limit or block prescriptions;
the occurrence of adverse safety events with our products; the
outcome (by judgment or settlement) and costs of legal,
administrative or regulatory proceedings, investigations or
inspections, including, without limitation, collective,
representative or class action litigation; competition; failure to
protect our intellectual property, to defend against the
intellectual property claims of others or to obtain third party
intellectual property licenses needed for the commercialization of
our products; and failure to comply with regulatory requirements
could result in adverse action by regulatory agencies.
These and other risks are described in greater detail in our
filings with the Securities and Exchange Commission. We may not
actually achieve the goals or plans described in our
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in
this press release are made only as of the date hereof, and we
disclaim any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of
this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20180416005062/en/
Acorda Therapeutics, Inc.Felicia Vonella,
914-326-5146fvonella@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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