Acorda Therapeutics Statement on AMPYRA® (dalfampridine) Annual Drug Safety Communication

ARDSLEY, N.Y. – July 25, 2012 – As part of a planned annual safety review, the U.S. Food and Drug Administration (FDA) has issued a safety update on AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. AMPYRA is being developed and marketed by Acorda Therapeutics, Inc. (Nasdaq: ACOR).

The Company’s Risk Evaluation Mitigation Strategy (REMS) for AMPYRA includes a commitment to provide annual post-marketing experience data to the FDA. The information in the annual FDA drug safety communication is based on data reported from March 2010 through March 2011.

These data showed no new safety signals related to seizure risk with AMPYRA, and are consistent with the data from clinical trials of AMPYRA.

This FDA communication clarifies prescribing information and continues to recommend that physicians monitor kidney function and for seizure activity. It also informs physicians and patients that the majority of seizures happened within days to weeks after starting the recommended dose and in patients having no history of seizures.

From March 2010 through March 2011, approximately 46,000 people with multiple sclerosis (MS) filled at least one prescription for AMPYRA. Among those patients, there were 82 confirmed reports of seizure. This rate is consistent with that seen in AMPYRA clinical trials. 

AMPYRA is contraindicated in patients with moderate or severe renal impairment, and the FDA continues to recommend that kidney function be checked in patients before starting AMPYRA. The FDA additionally recommends physicians evaluate kidney function at least once a year for patients taking AMPYRA, as calculated from a routine blood test.

The Company does not expect any changes to the REMS program or post-marketing commitments as a result of this update.

Important Safety InformationAMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.

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