Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced that a new analysis of AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg data examining walking improvement in treatment responders has been presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). AMPYRA is an oral medication approved by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.
Using recently published consensus expert group criteria1, an independent analysis of pooled AMPYRA Phase 3 trial data showed that the statistically significant improvement in Multiple Sclerosis Walking Scale (MSWS-12) score reported in the pivotal studies is also clinically significant and meaningful for people with MS. This new analysis indicates that the MSWS-12 score differences, 7.30 points between AMPYRA responders and placebo, and 7.02 points between AMPYRA responders and all non-responders, exceed the consensus expert group criteria and thereby satisfy the requirements for clinically significant and meaningful differences.
An AMPYRA responder was defined as a person who walked faster on the Timed 25-Foot Walk at 3 of 4 on-treatment assessments than at any of the 5 off-treatment assessments.
“Walking is a critical function, and walking disability is often cited by people with MS as the most concerning aspect of their disease,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “This study highlights that the MSWS-12 is an important tool in evaluating how walking improvements can translate into real world benefit to patients, and that patients who respond to AMPYRA can experience a clinically meaningful improvement in their walking.”
Acorda is developing and commercializing AMPYRA in the United States. Biogen Idec has licensed the rights to develop and commercialize prolonged-release fampridine tablets outside the United States from Acorda Therapeutics, Inc. Biogen Idec is presenting additional clinical data on prolonged-release fampridine at ECTRIMS.
This study was conducted by Dr. Jeremy Hobart, Peninsula College of Medicine and Dentistry (Devon, UK) and funded by Acorda Therapeutics, Inc.
Source: Acorda Therapeutics