- Acorda Therapeutics Committed to Working with FDA
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced that the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter (CRL) for the New Drug Application
(NDA) for PLUMIAZTM (diazepam) Nasal Spray for the treatment
of people with epilepsy who experience cluster
seizures.
A CRL is a communication from the FDA that informs a company that their
review of the NDA is complete and the application cannot be approved in
its present form. The Company is currently developing a response to
address the items outlined in the letter.
“There is an urgent need for new treatments for people with epilepsy who
experience cluster seizures. We are committed to the development and
commercialization of PLUMIAZ, a potential therapeutic option for these
individuals,” said
Ron Cohen
, M.D., Acorda’s President and CEO. “We are
evaluating the Complete Response Letter and expect to work closely with
the FDA to address the items outlined in the letter and refile the NDA
for PLUMIAZ. We expect to provide further detail as our discussions with
the FDA progress.”
Based on the requirements for approval outlined in the letter, the
Company does not expect PLUMIAZ to receive FDA approval in 2014.
Of the approximately 2.8 million people in the United States with
epilepsy, it is estimated that about 175,000 experience cluster
seizures, also known as acute repetitive seizures or bouts of increased
seizure activity. These patients may experience cluster seizures even
though they generally are on stable regimens of antiepileptic
medications (AEDs). Currently, many of these individuals do not find the
currently available outpatient therapy acceptable and default to
emergency room care or no care at all. PLUMIAZ potentially offers a more
viable treatment option. PLUMIAZ has received orphan drug designation
for the treatment of cluster seizures.
About Epilepsy
Epilepsy is a neurological condition that produces seizures affecting a
variety of mental and physical functions. Seizures are symptoms of
abnormal brain activity, and occur when a brief, strong surge of
electrical activity affects part or all of the brain.
About Acorda Therapeutics
Founded in 1995, Acorda
Therapeutics is a biotechnology company focused on developing
therapies that improve the lives of people with neurological disorders.
Acorda markets three FDA-approved therapies including: AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, a treatment
to improve walking in patients with multiple sclerosis (MS); ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity; and QUTENZA®
(capsaicin) 8% Patch, for the management of neuropathic pain
associated with postherpetic neuralgia. AMPYRA is marketed outside the
United States as FAMPYRA® (prolonged-release fampridine
tablets) by Biogen Idec under a licensing agreement from Acorda.
Acorda has one of the leading pipelines in the industry of novel
neurological therapies. The Company is currently developing six
clinical-stage therapies and one preclinical stage therapy that address
a range of disorders including post-stroke deficits, epilepsy, stroke,
peripheral nerve damage, spinal cord injury, neuropathic pain, and heart
failure. For more information, please visit the Company’s website at: www.acorda.com.
Forward-Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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 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 Plumiaz (our trade name for 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 Diazepam Nasal Spray or other products under
development; the occurrence of adverse safety events with our products;
delays in obtaining or failure to obtain regulatory approval of or to
successfully market Fampyra outside of the U.S. and our dependence on
our collaboration partner Biogen Idec in connection therewith;
competition, including the impact of generic competition on Zanaflex
Capsules revenues; 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; failure to comply with regulatory
requirements could result in adverse action by regulatory agencies; and
the ability to obtain additional financing to support our operations.
These and other risks are described in greater detail in Acorda
Therapeutics' filings with the Securities & Exchange Commission. Acorda
may not actually achieve the goals or plans described in its
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 Acorda disclaims any
intent or obligation to update any forward-looking statements as a
result of developments occurring after the date of this release.
Source: Acorda Therapeutics, Inc.