Acorda Announces FDA Acceptance of New Drug Application for INBRIJA™ (levodopa inhalation powder)
February 20 2018 - 6:00AM
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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version on businesswire.com: http://www.businesswire.com/news/home/20180220005557/en/
Acorda Therapeutics, Inc.Felicia Vonella,
914-326-5146fvonella@acorda.com
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