ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for filing its New Drug
Application (NDA) for INBRIJA. INBRIJA is an investigational inhaled
levodopa treatment for symptoms of OFF periods in people with
Parkinson’s disease taking a carbidopa/levodopa regimen. Under the
Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of
October 5, 2018.
“OFF periods greatly disrupt the lives of people living with
Parkinson’s, and there is a significant need for new treatments in this
community,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda.
“We are excited about the potential to bring this highly innovative
treatment option to people living with Parkinson’s, and look forward to
working with the FDA throughout the review process.”
The NDA for INBRIJA includes data from a Phase 3 safety and efficacy
study (SPAN-PD), as well as results from two long-term safety studies in
people with Parkinson’s disease. Findings from these studies support the
filing of INBRIJA for use on an as-needed basis to address symptoms of
OFF periods in patients on a carbidopa/levodopa regimen. Data from the
SPAN-PD trial were presented at the International Congress of
Parkinson’s Disease and Movement Disorders (MDS) in June 2017.
“People with Parkinson’s and physicians need more options to manage this
disease,” said Todd Sherer, Ph.D., CEO of The Michael J. Fox Foundation.
“Inhaled delivery of levodopa could help the many people living with
Parkinson’s facing the complication of OFF periods as their disease
progresses.”
The INBRIJA Phase I and II clinical studies were funded in part by
grants from The Michael J. Fox Foundation for Parkinson’s Research.
About Parkinson’s and OFF periods
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. Parkinson’s is
a progressive neurodegenerative disorder resulting from the gradual loss
of certain neurons responsible for producing dopamine. 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 symptoms. This
re-emergence can occur even when an individual’s treatment regimen has
been optimized.
About INBRIJA™
(CVT-301, 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 to 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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Acorda Therapeutics, Inc.
Felicia Vonella, 914-326-5146
fvonella@acorda.com
Source: Acorda Therapeutics, Inc.