ARDSLEY, N.Y.--(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:
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PRESENTATION TIME
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ABSTRACT #
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TITLE
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PRESENTER
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4:06 PM PT
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3102
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Inhaled Levodopa Administered With Oral Carbidopa/Levodopa
for Early Morning OFF Symptoms in Patients with Parkinson’s
Disease: Exploratory Efficacy Analysis
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Stuart H. Isaacson, MD
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4:18 PM PT
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3008
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Inhaled Levodopa Administered With Oral Carbidopa/Levodopa
for Early Morning OFF Symptoms in Patients with Parkinson’s
Disease: Safety Assessment
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Robert A. Hauser, MD
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4:30 PM PT
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1484
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Long-Term Pulmonary Safety of Inhaled Levodopa in Parkinson’s
Disease Subjects with Motor Fluctuations: a Phase 3
Open-Label Randomized Study
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Charles Oh, MD
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4:54 PM PT
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1454
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Long-term Efficacy of Inhaled Levodopa in Parkinson’s Disease
Subjects with Motor Fluctuations: a Phase 3 Open-Label
Randomized Study
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Charles OH, MD
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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 INBRIJA
TM
(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.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180416005062/en/
Acorda Therapeutics, Inc.
Felicia Vonella, 914-326-5146
fvonella@acorda.com
Source: Acorda Therapeutics, Inc.