Acorda Therapeutics Inc. (ACOR) announced that it has received marketing approval from the U.S. FDA for AMPYRA, an oral treatment to improve walking in patients with multiple sclerosis. The company stated that AMPYRA demonstrated efficacy in people with all four major types of multiple sclerosis; relapsing remitting, secondary progressive, progressive relapsing and primary progressive. AMPYRA can be used alone or with existing multiple sclerosis therapies, including immunomodulator drugs.
AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine, which was previously called fampridine. The FDA granted AMPYRA orphan drug status, which will provide seven years of market exclusivity for the drug.
The FDA approved AMPYRA with a risk evaluation and mitigation strategy program comprising a medication guide and communication plan. The goals of the communication plan are to inform patients about the serious risks, including seizures, associated with use of higher than recommended doses of AMPYRA therapy, and the change of the established name from fampridine to dalfampridine.
The company expects AMPYRA to be commercially available in the United States in March 2010. AMPYRA will be distributed exclusively through a network of specialty pharmacies and coordinated by AMPYRA Patient Support Services.
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