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|Acorda Therapeutics Announces Positive AMPYRA® (dalfampridine) Phase 2 Data in People with Post-Stroke Deficits|
“There were clear efficacy signals in the dalfampridine-ER post-stroke
deficits trial and we therefore plan to proceed with a clinical
development program for this indication. A top-line analysis of the data
found dalfampridine-ER improved walking for people with mobility
impairment resulting from ischemic stroke. Dalfampridine-ER treatment
was also associated with a positive change versus placebo on a scale of
functional independence in this study,” said
This study included 83 participants who had experienced an ischemic stroke at least six months prior to enrollment and had chronic motor deficits. As part of the crossover design, participants received both dalfampridine-ER 10 mg and placebo for 14 days twice daily, with a wash-out period in between during which participants received placebo. The primary goals of the study were to assess safety and tolerability, as well as to explore various efficacy measures.
Key Safety Findings from Post-Stroke Deficits Trial
The safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in multiple sclerosis (MS).
The most common adverse events reported in the study were dizziness (10.4% dalfampridine-ER, 2.5% placebo), nausea (3.9% dalfampridine-ER, 6.2% placebo), fatigue (5.2% dalfampridine-ER, 3.7% placebo), insomnia (5.2% dalfampridine-ER, 2.5% placebo) and arthralgia (2.6% dalfampridine-ER, 3.7% placebo).
Three participants experienced a seizure during the study. One occurred while the participant was taking placebo (without prior exposure to dalfampridine-ER), one occurred while the participant was taking dalfampridine-ER, and one occurred due to an intentional overdose of dalfampridine-ER. The overdose was judged by the study investigator to be a suicide attempt related to a recent family tragedy. All three participants recovered fully.
Key Efficacy Findings from Post-Stroke Deficits Trial
Improvement in walking was measured by the Timed 25-Foot Walk (T25FW). Using the full crossover design, walking speed increased while participants were taking dalfampridine-ER compared to placebo (p < 0.05).
Participants also showed a positive change on the Functional Independence Measurement (FIM) scale while taking dalfampridine-ER compared to placebo. The FIM scale assesses an individual’s ability to perform daily tasks such as bathing, grooming, eating, and walking independently.
Other exploratory efficacy measures in the study are currently being analyzed.
Cerebral Palsy Study Update
A separate proof-of-concept trial including 24 participants explored the use of dalfampridine-ER 10 mg dosed twice daily in adults with cerebral palsy (CP).
The safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in MS. The most commonly reported adverse events were headache (12.5% dalfampridine-ER, 4.2% placebo), fatigue (12.5% dalfampridine-ER, 0% placebo), insomnia (8.3% dalfampridine-ER, 4.2% placebo), diarrhea (4.2% dalfampridine-ER, 4.2% placebo) and nausea (4.2% dalfampridine-ER, 4.2% placebo). There were no serious adverse events reported.
Efficacy data from this study suggested potential treatment activity on measures of walking and hand strength; however, these data are still being analyzed to determine if they are sufficiently robust to warrant further clinical studies.
The Company plans to present data from the post-stroke deficits and CP trials in appropriate medical forums following additional analysis of the data.
AMPYRA is approved by the
Webcast and Conference Call
To participate in the conference call, please dial 800-510-0219 (domestic) or 617-614-3451 (international) and reference the access code 93715573. The presentation will be available via a live webcast on the Investor section of www.acorda.com.
A replay of the call will be available from
Important Safety Information
Do not take AMPYRA if you have ever had a seizure or have certain types of kidney problems.
Take AMPYRA exactly as prescribed by your doctor.
You could have a seizure even if you never had a seizure before. Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50.
Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking AMPYRA.
AMPYRA may cause serious allergic reactions, including rare occurrence of anaphylaxis.
AMPYRA 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 AMPYRA in MS patients were urinary tract infection, trouble sleeping, dizziness, headache, nausea, weakness, back pain, and problems with balance.
Before taking AMPYRA tell your doctor if you are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You and your doctor should decide if you will take AMPYRA or breast-feed. You should not do both.
You are encouraged to report negative side effects of prescription drugs
About AMPYRA (dalfampridine)
AMPYRA is a potassium channel blocker approved as a treatment to improve
walking in patients with multiple sclerosis (MS). This was demonstrated
by an increase in walking speed. AMPYRA, which was previously referred
to as Fampridine-SR, is an extended release tablet formulation of
dalfampridine (4-aminopyridine, 4-AP), and is known as prolonged-,
modified, or sustained-release fampridine (FAMPYRA®) in some
In laboratory studies, dalfampridine extended release tablets has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged.
AMPYRA is being developed and commercialized in the U.S. by
AMPYRA is available by prescription in
Acorda markets AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in
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
Acorda has one of the leading pipelines in the industry 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