Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that new data
from a pharmacokinetics study on Diazepam Nasal Spray found comparable
pharmacokinetics (PK) whether the drug was administered during or
immediately after a seizure. These data were presented at the 67th
Annual Meeting of the American Epilepsy Society, in Washington, D.C.
Diazepam Nasal Spray is being developed for the treatment of people with
epilepsy who experience cluster seizures, also known as acute repetitive
"In this study, some patients received a dose of Diazepam Nasal Spray
while having a seizure, while others received the dose after their
seizure activity had ceased," said Adrian Rabinowicz, M.D., FAAN,
Acorda's Senior Vice President of Clinical Development and Medical
Affairs. "The results suggest that delivery of Diazepam Nasal Spray was
unaffected by the timing of dosage relative to seizure activity. It is
critical for a person with epilepsy who experiences cluster seizures
that treatment be administered as soon as possible after a cluster is
recognized, in order to prevent additional seizure activity."
This multicenter, open-label study was conducted in adults admitted to
an epilepsy monitoring unit for evaluation and management of epilepsy.
Of the 30 patients who completed the study, 10 were dosed during a
seizure, while the other 20 patients were dosed after their seizure
activity had ceased. Plasma concentrations of diazepam were measured for
a period of up to 12 hours following the dose.
The overall safety and tolerability of Diazepam Nasal Spray in this
study was consistent with systemic diazepam exposure established with
other diazepam products. The most common local adverse events were
related to the nasal route of delivery; most adverse events were mild
and transient, and resolved within a day. These local events were an
altered sense of taste and nasal discomfort, experienced by 26% and 23%
of study subjects respectively.
Other data from this study were previously presented at the 30th
biennial International Congress of the International League Against
Epilepsy and International Bureau for Epilepsy.
Acorda has submitted a New Drug Application for Diazepam Nasal Spray to
the U.S. Food and Drug Administration (FDA) and will rely upon the FDA's
previous findings of safety and efficacy for diazepam rectal gel.
About Epilepsy and Cluster Seizures/Acute Repetitive Seizures
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.
Of the approximately 2.75 million people in the United States with
epilepsy, it is estimated that about 175,000 experience cluster
seizures. Cluster seizures, also known as acute repetitive seizures, are
characterized by recognizable, recurring episodes of seizure clusters.
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
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.
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 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.
Jeff Macdonald, 914-326-5232