Note the word chronic.
This is also being used as a drug to help MS patients walk, see here:
http://ir.acorda.com/phoenix.zhtml?c=194451&p=irol-newsOtherArticle&ID=1701026&highlight=
This does bring up the question, if it helps stroke patients does that mean that demyelination occurs as part of the stroke damage?
http://ir.acorda.com/phoenix.zhtml?c=194451&p=irol-newsOtherArticle&ID=1656337&highlight=
Acorda Therapeutics, Inc. (Nasdaq: ACOR)
presented data showing that treatment with dalfampridine improved motor
function in a preclinical model of stroke, with treatment initiated at
least four weeks following the ischemic event. These data were presented
on February 2 at the American Heart Association/American Stroke
Association International Stroke Conference in New Orleans, LA.
Dalfampridine, also known as 4-aminopyridine, is the active chemical
ingredient in AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg.
“These are the first preclinical data to show an oral pharmacologic
treatment can improve function in chronic, or long term, stroke. We are
excited by these results and plan to begin proof-of-concept human
clinical trials of AMPYRA in people with chronic stroke later this
year,” said Andrew R. Blight, Ph.D., Acorda Therapeutics’ Chief
Scientific Officer. “The majority of the nearly seven million people in
the United States who live with the long term effects of a stroke have
motor function deficits, such as walking impairment, but there are no
established treatments other than physical therapy to address these
impairments.”
A late-breaking science presentation, entitled “Dalfampridine Improves
Sensorimotor Function in Rats with Chronic Deficits Following Middle
Cerebral Artery Occlusion,” presented by Acorda scientist Jennifer Iaci,
reviewed data from three study groups that received treatment beginning
four weeks after a permanent middle cerebral artery occlusion (pMCAO).
The neurological impairments that result are expected to be permanent by
four weeks, which represents the chronic stage of stroke. Each group
received three treatment phases over the course of the study: high and
low doses of dalfampridine, and placebo. The order of the treatment
phases was different for each group, with a 10 day washout period
between each phase.
Researchers assessed functional improvement using a battery of standard
motor function tests in both the forelimbs and hind limbs. In each of
the three study groups, treatment with dalfampridine resulted in
significant improvement in function compared to placebo across all
measures during the respective treatment periods. Improvements in the
high dose phase were consistently better than those seen in the low dose
phase.
“In addition to the seven million Americans living with the consequences
of a prior stroke, there are close to 800,000 people in the United
States who have new stroke events each year. The resulting disability
has a major impact on the person who suffers the stroke as well as on
their caregivers, and places a significant burden on the healthcare
system,” said Seth Finklestein, M.D., Chairman and Chief Scientific
Officer of Biotrofix, a preclinical research organization that conducted
research for this study in partnership with Acorda. “These are the first
data from a well-controlled preclinical study that have demonstrated
improvement in motor function related to walking and upper body
movement. Developing a therapeutic option that can improve function
would represent a potential major advance in the standard of care for
stroke survivors.”
Acorda plans to begin a proof-of-concept trial of AMPYRA in stroke by
the end of 2012. (I'm going to try to find out how to get involved)Go here to apply for the trial:
http://oc1dean.blogspot.com/2012/06/phase-1phase-2-study-of-dalfampridine.html
This study will evaluate the use of AMPYRA in stroke
patients with chronic neurologic deficits, including walking impairment.
AMPYRA is approved 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 known as prolonged-,
modified-, or sustained-release fampridine (FAMPYRA®) in some
countries outside the United States.
Important Safety Information
AMPYRA can cause seizures; the risk of seizures increases with
increasing AMPYRA doses. AMPYRA is contraindicated in patients with a
prior history of seizure. Discontinue AMPYRA use if seizure occurs.
AMPYRA is contraindicated in patients with moderate or severe renal
impairment (CrCl less-than or equal to 50 mL/min); the risk of seizures
in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown,
but AMPYRA plasma levels in these patients may approach those seen at a
dose of 15 mg twice daily, a dose that may be associated with an
increased risk of seizures; estimated CrCl should be known before
initiating treatment with AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same.
Urinary tract infections were reported more frequently as adverse
reactions in patients receiving AMPYRA 10 mg twice daily compared to
placebo.
The most common adverse events (incidence greater-than or equal to 2%
and at a rate greater than the placebo rate) for AMPYRA in MS patients
were urinary tract infection, insomnia, dizziness, headache, nausea,
asthenia, back pain, balance disorder, multiple sclerosis relapse,
paresthesia, nasopharyngitis, constipation, dyspepsia, and
pharyngolaryngeal pain.
For full U.S. Prescribing Information and Medication Guide for AMPYRA,
please visit: www.AMPYRA.com.
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 sold under a license from
Alkermes Pharma Ireland Limited and manufactured by Alkermes Pharma
Ireland Limited and other parties.
The Company also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity.
Acorda is developing an industry-leading pipeline of novel neurological
therapies. The Company is studying AMPYRA to improve a range of
functional impairments caused by MS, as well as its use in other
neurological conditions, including cerebral palsy and chronic stroke. In
addition, Acorda is developing clinical stage compounds AC105 for acute
treatment of spinal cord injury and GGF2(see here for GGF2) for treatment of heart
failure. GGF2 is also being investigated in preclinical studies as a
treatment for neurological conditions such as stroke and spinal cord
injury. Additional preclinical programs include rHIgM22, a remyelinating
monoclonal antibody for the treatment of MS, and chondroitinase, an
enzyme that encourages nerve plasticity in spinal cord injury.
Ask your doctor, this was reported on Feb. 3, 2012 so they should be well aware of this by now.
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