ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that data showing treatment with dalfampridine improved motor function in a preclinical model of post-stroke deficits have been published online ahead of print on May 7th in Stroke, a peer-reviewed journal of the American Heart Association. The data will be included in the July 2013 print edition of Stroke. Dalfampridine is the active ingredient in AMPYRA (dalfampridine) Extended Release Tablets, 10 mg.
These preclinical data showed that dalfampridine can improve motor function long after a stroke, when the natural recovery process has ended and stable deficits are likely to persist over time. The results informed our decision to conduct a recently completed proof-of-concept study in humans, which indicated that dalfampridine improved walking in people with post-stroke deficits, said Andrew R. Blight, Ph.D., Acorda Therapeutics Chief Scientific Officer. More than half of the nearly seven million people in the United States who live with the long term effects of a stroke have lasting mobility impairment, but there are no established treatments other than physical therapy to address these impairments. New therapies are needed, and we are moving forward with development of dalfampridine extended release tablets in this indication.
The paper, entitled Dalfampridine Improves Sensorimotor Function in Rats with Chronic Deficits after Middle Cerebral Artery Occlusion, reported data from two studies that initiated treatment four or eight weeks after a permanent middle cerebral artery occlusion (pMCAO). Like the human condition, a certain amount of recovery occurs during the first several weeks after pMCAO, and there is little or no improvement in function after 4 weeks. This represents a chronic stage of stroke. In one study at 4 weeks post pMCAO, animals received high, low and vehicle doses of dalfampridine, in different orders with a 10 day washout period between each treatment phase. In a second study, animals were treated at 8 weeks after pMCAO with ascending doses of dalfampridine.
Researchers assessed functional improvement using standard motor function tests in both the forelimbs and hind limbs. In each study, treatment with dalfampridine resulted in significant improvement in function compared to vehicle 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.
Data included in the Stroke paper were first presented at the 2012 American Heart Association/American Stroke Association International Stroke Conference, held in New Orleans, Louisiana. This research was conducted in collaboration with Biotrofix, a preclinical research organization.
In April 2013, Acorda completed an 83-participant proof-of-concept clinical trial that showed evidence of improved walking in people with post-stroke deficits treated with dalfampridine-ER tablets. Other exploratory efficacy measures in the study are currently being analyzed. The safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in multiple sclerosis (MS). Post-stroke deficits refer to chronic neurological deficits, such as impaired walking, motor and sensory function, and dexterity that persist in people following a stroke.
Based on the findings of this proof-of-concept study, the Company is proceeding with a clinical development program for this indication.
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.
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