New MS Drug Approved

1/26/2010
The FDA has approved Acorda Therapeutics’ Ampyra (dalfampridine) extended-release tablets to improve walking in patients with all 4 types of multiple sclerosis (relapsing remitting, secondary progressive, progressive relapsing, and primary progressive). Ampyra can be used alone or with other multiple sclerosis therapies, including immunomodulator drugs. The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) program that includes a Medication Guide and communication plan. The objectives of the communication plan are to inform patients about the serious risks, including seizures, associated with use of higher than recommended Ampyra doses, and the change of the established name from fampridine to dalfampridine. Acorda expects Ampyra to be commercially available in March 2010.
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