Drug Shown to Help People With MS Walk Better

Acorda Therapeutics, Inc. announced data analyses showing that people with multiple sclerosis (MS) who responded to AMPYRA Extended Release Tablets had comparable improvements in their walking regardless of baseline walking speed or overall level of MS-related disability. In addition, AMPYRA responders, regardless of baseline disability, showed clinically meaningful improvement on the 12-Item MS Walking Scale (MSWS-12), a patient-based questionnaire that measures the impact of MS on the patient's reported ability to perform daily activities related to walking.

The results will be presented at the 63rd American Academy of Neurology (AAN) Annual Meeting being held April 9-16 in Honolulu, Hawaii.

"Walking impairment is one of the most common and serious functional deficits caused by MS, but often people with MS and their physicians do not discuss walking issues until the level of impairment is severe," said Ron Cohen, M.D., Acorda's President and CEO. "These new analyses of our clinical data highlight that people with MS can experience a meaningful benefit with AMPYRA across all degrees of walking impairment. This also applies to patients with walking difficulties that may be less obvious and not immediately appreciated by others."

As part of this analysis, 394 participants who received 10 mg twice daily in AMPYRA Phase 2 and Phase 3 clinical trials were stratified by two separate criteria: baseline Expanded Disability Status Scale (EDSS) score and baseline walking speed.

A Timed Walk responder was defined as a person who walked faster on at least three of four on-treatment assessments compared to the fastest of five off-treatment assessments. When stratified by severity of EDSS score, both the rate of response and the average percent improvement in walking speed among AMPYRA Timed Walk responders were comparable across the five subgroups and were consistently greater than changes in both AMPYRA non-responders and patients receiving placebo.

A separate analysis of pooled data from two placebo-controlled AMPYRA Phase 3 clinical trials demonstrated that AMPYRA responders transitioning from the placebo-controlled trials into open-label studies experienced a rapid loss of walking improvement after discontinuing therapy during the transition period Re-initiation of therapy resulted in recovery of walking speed improvement among previous responders by the first open-label study visit, which occurred 2 weeks after restarting treatment.

The average walking speed improvement among responders was 27.7% from baseline at the conclusion of the placebo-controlled trials; after withdrawal from therapy, responder walking speed decreased to 4.3% above baseline. Following re-initiation of therapy, responders showed an average 24.3% increase from the original baseline. This indicates that responders can return to the level of walking improvement experienced before interruption of therapy.

The study also found that the safety profile observed in the long-term extension trials was consistent with that seen in double-blind clinical trials; no new safety signals emerged in the open label extension. Approximately 94% of participants who completed the placebo-controlled clinical trials elected to enroll in the extension study. Participants in the extension study were followed for up to 3.5 years on therapy for this analysis.

AMPYRA is marketed in the United States by Acorda Therapeutics, Inc. It is approved in the Unites States as a treatment to improve walking in people with MS. This was demonstrated by an increase in walking speed.

AMPYRA

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