Acorda Announces Initiation of Phase 3 Clinical Trial for Dalfampridine in Post-Stroke Walking Deficits
December 15 2014 - 7:01AM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced
that the first patient has been enrolled in a Phase 3 clinical
trial of dalfampridine for the treatment of post-stroke walking
deficits (PSWD).
“Approximately three and a half million stroke survivors in the
U.S. suffer ongoing mobility issues. This is a significant unmet
medical need, as there are no approved medicines to improve walking
in people with PSWD,” said Ron Cohen, M.D., Acorda Therapeutics'
President and CEO. “Our Phase 2 trial of dalfampridine in PSWD
produced promising data, showing significant improvements in
walking speed. This larger Phase 3 trial will enroll a similar
patient population, and include a number of assessments to evaluate
the effect of dalfampridine in improving their walking.”
This multi-center, double-blind, randomized trial is expected to
enroll approximately 540 participants who have experienced an
ischemic stroke at least six months prior to enrollment.
Participants will receive 10 mg dalfampridine, 7.5 mg
dalfampridine, or placebo twice daily for 12 weeks. The primary
endpoint of the study is the percentage of patients taking
dalfampridine who demonstrate at least a 20% improvement in the 2
Minute Walk Test (2MinWT) compared to those receiving placebo. The
2MinWT measures the distance a person can walk in 2 minutes. Other
measures will include the Timed Up and Go, which assesses mobility
and balance, as well as clinician and patient-reported measures.
The study also includes evaluation of safety and tolerability.
More details about the study, including enrollment criteria and
contact information for study sites, can be found at:
http://clinicaltrials.gov/ct2/show/NCT02271217 and
www.acorda.com.
Phase 2 Study Results
In April 2013, the Company announced results from a Phase 2
study which showed participants had a significantly greater
improvement in walking speed when receiving dalfampridine over two
weeks of treatment than when receiving placebo, as measured by the
Timed 25-Foot Walk test (T25FW). Safety findings for the study were
consistent with previous clinical trials and post-marketing
experience of dalfampridine in people with multiple sclerosis.
About Stroke
About 800,000 new cases of stroke occur annually in the U.S.
Approximately 3.5 million stroke survivors in U.S. have ongoing
mobility issues, and there are no currently approved medications
for such impairments.
Dalfampridine Important Safety Information
Dalfampridine is the active ingredient in AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, approved by the
FDA as a treatment to improve walking in patients with multiple
sclerosis (MS). This was demonstrated by an increase in walking
speed. Dalfampridine extended release tablets have not been
evaluated by FDA for the treatment of post-stroke deficits.
The FDA-approved form of dalfampridine (AMPYRA) is
contraindicated in patients with a history of seizures, or with
moderate or severe renal impairment, or history of hypersensitivity
to dalfampridine or 4-aminopyridine.
Dalfampridine can cause seizures. The risk of seizures increases
with increasing dalfampridine doses. Discontinue dalfampridine and
do not restart if seizure occurs.
Dalfampridine should not be taken with other forms of
4-aminopyridine (4-AP, fampridine), since the active ingredient is
the same.
The most common adverse events for dalfampridine in MS patients
were urinary tract infection, trouble sleeping, dizziness,
headache, nausea, weakness, back pain, and problems with
balance.
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 markets three FDA-approved therapies, including
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a
treatment to improve walking in patients with multiple sclerosis
(MS), as demonstrated by an increase in walking speed. The Company
has one of the leading pipelines in the industry of novel
neurological therapies. Acorda is currently developing a number of
clinical and preclinical stage therapies. This pipeline addresses a
range of disorders including post-stroke walking deficits,
Parkinson’s disease, epilepsy, neuropathic pain, heart failure, MS,
and spinal cord injury.
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 the ability to realize the
benefits anticipated from the Civitas transaction and to
successfully integrate Civitas' operations into our operations; 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, 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, or any other products under development;
we may need to raise additional funds to finance our expanded
operations and may not be able to do so on acceptable terms; 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; 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 Acorda Therapeutics' filings with
the Securities and 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.
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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