Diazepam Nasal Spray Demonstrates Comparable Bioavailability to Diazepam Rectal Gel in Pharmacokinetic Study
Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced data from a Phase 1 study that showed a single dose of
20 mg Diazepam Nasal Spray had comparable plasma bioavailability to 20
mg of diazepam rectal gel. Diazepam Nasal Spray is being developed for
the treatment of people with epilepsy who experience cluster seizures,
also known as acute repetitive seizures. These pharmacokinetic data were
presented at the 65th American Academy of Neurology Annual
Meeting in San Diego, CA.
“Currently, the rectally-administered form of diazepam is the only
FDA-approved outpatient therapy for people with epilepsy who experience
cluster seizures. We believe that a nasal spray formulation offers a
more accessible and socially acceptable therapeutic alternative dosage
form for people with epilepsy,” said Enrique Carrazana, M.D., Acorda’s
Chief Medical Officer. “This new mode of diazepam delivery can provide
an important new treatment option for people with epilepsy and their
caregivers.”
This was an open-label crossover study conducted in 24 healthy
volunteers, who received a single dose of 20 mg diazepam nasal spray and
a single dose of 20 mg diazepam rectal gel. Both the nasal spray and
rectal gel were generally well tolerated and showed similar safety
profiles, with mild nasal and pharyngeal irritation more frequently
observed with the nasal spray.
Acorda plans to submit a 505(b)(2)-type New Drug Application (NDA) for
Diazepam Nasal Spray to the U.S. Food and Drug Administration (FDA) in
2013 and rely upon FDA’s previous findings of safety and efficacy for
the reference listed drug, diazepam rectal gel. The Company has
completed three pharmacokinetic studies of Diazepam Nasal Spray that
will be included in the NDA submission.
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.
The Centers for Disease Control and Prevention (CDC) estimates that
approximately 2.3 million adult Americans have active epilepsy. Cluster
seizures, also known as acute repetitive seizures, are characterized by
recognizable, recurring episodes of seizure clusters. In the U.S., there
are up to 175,000 people with epilepsy who experience cluster seizures
despite being on stable regimens of antiepileptic drugs (AEDs).
About Acorda
Therapeutics
Acorda Therapeutics is a biotechnology company focused on developing
therapies that restore function and improve the lives of people with MS,
spinal cord injury and other neurological conditions.
Acorda markets AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in the United
States as a treatment to improve walking in patients with multiple
sclerosis (MS). This was demonstrated by an improvement in walking
speed. AMPYRA is marketed outside the United States as FAMPYRA®
(prolonged-release fampridine tablets) by Biogen Idec under a licensing
agreement from Acorda. AMPYRA and FAMPYRA are manufactured under license
from Alkermes Pharma Ireland Limited.
The Company also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity. Acorda
also receives sales royalties on tizanidine hydrochloride capsules, an
authorized generic version of ZANAFLEX CAPSULES, distributed by Actavis,
Inc. under its agreement with Acorda.
Acorda has an industry-leading pipeline of novel neurological therapies.
The Company is developing Diazepam Nasal Spray for treatment of certain
epileptic seizures. It is also studying AMPYRA to improve a range of
functional impairments caused by MS, as well as its potential for use in
other neurological conditions, including cerebral palsy and post-stroke
deficits. In addition, Acorda is developing clinical stage compounds
AC105 for acute treatment of spinal cord injury, GGF2 for treatment of
heart failure and rHIgM22, a remyelinating monoclonal antibody, for the
treatment of MS. GGF2 is also being investigated in preclinical studies
as a treatment for neurological conditions such as stroke and spinal
cord injury. Chondroitinase, an enzyme that encourages nerve plasticity
in spinal cord injury, is in preclinical development.
Acorda 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 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.
