Clinical trial data on AMPYRA Extended Release Tablets to be presented at AAN Annual meeting

Apr 13 2010

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that four new analyses of clinical trial data on AMPYRA™ (dalfampridine) Extended Release Tablets 10 mg are being presented at the 62^nd American Academy of Neurology (AAN) Annual meeting. AMPYRA is an oral medication approved by the U.S. Food and Drug Administration (FDA) on January 22, 2010 as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed.

“AMPYRA is a new therapy, the first ever with an indication to improve walking in MS”

"AMPYRA is a new therapy, the first ever with an indication to improve walking in MS," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "The data being presented at the AAN meeting include analyses of large numbers of patients receiving therapy for up to two and a half years, providing new information on the safety and efficacy of the drug during chronic use."

Two platform presentations on AMPYRA data are included in today's Scientific Session on Multiple Sclerosis:

Platform Presentation - Extension Studies

The first presentation is an analysis of long-term data from open-label extension studies of two completed Phase 3 trials as of November 30, 2008, the cut-off date for the safety update for the New Drug Application (NDA) of AMPYRA. Patients receiving AMPYRA in the placebo-controlled trials were classified as either Timed Walk responders or non-responders based on their walking speed change as measured by the Timed 25-Foot Walk. A Timed Walk responder was defined as a patient who showed faster walking speed for at least 3 of 4 visits while taking AMPYRA compared to the fastest of 5 off-drug visits.

In the longer of the two extension studies, AMPYRA Timed Walk responders as a group continued to show improvement over their average baseline walking speed after 2.5 years, while Timed Walk non-responders did not. Both Timed Walk responders and non-responders showed a gradual and similar decrease in walking speed over time. Similar results were seen in the shorter extension study after 1.2 years. In both extension studies, the safety profile of AMPYRA was similar to that observed in double-blind trials lasting up to 14 weeks.

In the longer of the two extension trials, the approximate total exposure to Ampyra was 565 patient-years as of the cut-off date and there were four seizure-related events, with a fifth patient experiencing a seizure 22 days after discontinuation of study drug. There were no reports of seizure in the shorter of the two extension trials as of the cut-off date, with 193 patient-years of exposure to Ampyra.

Platform Presentation - Double Blind Studies

The second platform presentation is a pooled efficacy analysis of 631 patients who participated in one Phase 2 and two Phase 3 AMPYRA clinical trials (394 patients received AMPYRA 10 mg twice daily; 237 received placebo). Across the three studies, 37.3% of patients who received AMPYRA qualified as Timed Walk responders compared to 8.9% of patients who received placebo. The AMPYRA-treated responders showed an average improvement in walking speed of 25.3%.

In addition, AMPYRA-treated patients who did not respond to therapy experienced changes from baseline that were similar to those in the placebo group, indicating the trial design effectively separated treatment effects from unrelated changes in disease course.

Poster Presentations

The pooled Phase 2 and Phase 3 data were also analyzed in two separate poster presentations that will be presented on Thursday, April 15. The first analysis showed that response to AMPYRA was independent of gender, age, body mass index, MS type, baseline disability score as measured by the Expanded Disability Status Scale (EDSS), or disease duration. Response rate was also independent of treatment with common immunomodulator drugs. Among patients who responded to AMPYRA, 36.8% were taking interferons, 37.1% were taking glatiramer acetate and 27.3% were taking natalizumab; 39.8% were not taking immunomodulator therapy.

A second analysis compared response to AMPYRA in patients based on baseline walking speed, which ranged from 0.3-4.8 feet per second. The responder rate and percent improvement in walking speed in patients treated with AMPYRA were similar across the entire range of baseline walking speeds represented in the studies.

SOURCE Acorda Therapeutics, Inc.