Acorda Therapeutics, Inc. (ACOR) said that a proof-of-concept study found dalfampridine extended release or ER tablets, marketed as AMPYRA Extended Release Tablets, 10 mg, improved walking in people with post-stroke deficits. Post-stroke deficits refer to chronic neurological deficits, such as impaired walking, motor and sensory function and manual dexterity that persist in people who have had a stroke.
According to Ron Cohen, M.D., Acorda's President and Chief Executive, "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."
Following the completion of the analysis, the company intends to discuss the development program with the FDA. There are over seven million stroke survivors in the U.S., and about half of them have some lasting mobility impairment.
The trial, whose primary goals were to assess safety and tolerability, and to explore various efficacy measures, included 83 participants who had experienced an ischemic stroke at least six months prior to enrollment and had chronic motor deficits. Under 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.
Acorda Therapeutics noted that the safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in multiple sclerosis or MS.
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