Acorda to Discontinue Development of PLUMIAZ for Treatment of Epilepsy Seizure Clusters
May 20 2016 - 6:00AM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
will discontinue development of PLUMIAZTM (diazepam) Nasal Spray,
an investigational therapy being studied for the treatment of
seizure clusters in people with epilepsy. Data from the ongoing
clinical trials do not demonstrate its bioequivalence to Diastat®
rectal gel, needed to re-file the New Drug Application (NDA) under
section 505(b)(2). Specifically, the data demonstrated unexpectedly
lower nasal mucosa absorption of diazepam in persons with epilepsy
compared to studies in healthy volunteers.
“We are very disappointed by this outcome, and for those in the
epilepsy community who experience seizure clusters. I want to thank
the many clinicians, caregivers, people with epilepsy and their
families involved with the PLUMIAZ clinical studies for their
efforts to advance care for people with seizure clusters,” said Ron
Cohen, M.D., Acorda’s President and CEO. “We will continue to focus
on development of our other high potential pipeline programs,
including CVT-301 and tozadenant for Parkinson’s disease, and
dalfampridine for post-stroke walking difficulty.”
Acorda is in communication with study investigators to
discontinue all ongoing clinical trials and assist in the
transition of study participants. The Company will present the data
at a future medical meeting.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a
biotechnology company focused on developing therapies that restore
function and improve the lives of people with neurological
disorders.
Acorda has an industry leading pipeline of novel neurological
therapies addressing a range of disorders, including Parkinson’s
disease, post-stroke walking difficulty, migraine, and multiple
sclerosis. Acorda markets three FDA-approved therapies,
including AMPYRA® (dalfampridine) Extended Release Tablets, 10
mg.
For more information, please visit the Company’s website
at: www.acorda.com.
Forward Looking Statements
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 complete the Biotie
transaction on a timely basis or at all; the ability to realize the
benefits anticipated from the Biotie and Civitas transactions,
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; the ability to
successfully integrate Biotie’s operations and Civitas’ operations,
respectively, into our operations; we may need to raise additional
funds to finance our expanded operations and may not be able to do
so on acceptable terms; our ability to successfully market and sell
Ampyra in the U.S.; third party payers (including governmental
agencies) may not reimburse for the use of Ampyra or our other
products at acceptable rates or at all and may impose restrictive
prior authorization requirements that limit or block prescriptions;
the risk of unfavorable results from future studies of Ampyra or
from our other research and development programs, including
CVT-301, Plumiaz (diazepam) Nasal Spray, or any other acquired or
in-licensed programs; we may not be able to complete development
of, obtain regulatory approval for, or successfully market CVT-301,
Plumiaz, any other products under development, or the products that
we would acquire if we complete the Biotie transaction; the
occurrence of adverse safety events with our products; delays in
obtaining or failure to obtain and maintain regulatory approval of
or to successfully market Fampyra outside of the U.S. and our
dependence on our collaborator Biogen in connection therewith;
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 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
release.
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version on businesswire.com: http://www.businesswire.com/news/home/20160520005142/en/
Acorda TherapeuticsJeff Macdonald, (914)
326-5232jmacdonald@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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