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Ampyra (formerly fampridine SR) Approved by FDA

1/25/2010

The U.S. Food and Drug Administration (FDA) has approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR), an oral medication to improve walking in people with MS. Acorda Therapeutics, which will market the drug in the U.S., expects Ampyra to be commercially available in the United States in March 2010. As of this time, the cost has not been reported.

The announcement has been eagerly anticipated by the MS community: 2004 was the last time the FDA approved any therapy for MS. It is also the first therapy approved specifically to treat a MS symptom.

Ampyra has been shown to improve walking ability in people with all types of MS. In two phase III clinical trials, 35 and 43 percent of people with MS experienced a consistent improvement in their walking speed, increasing it by about 25 percent.

However, a spokesperson from Acorda said that since it is impossible to predict who will benefit from Ampyra, individuals should discuss with their doctors whether they should begin the therapy. The FDA has warned that Ampyra should not be taken by people with a history of seizures or by people having mild to severe renal impairment.Ampyra can be taken alone, or with existing MS therapies, including immunomodulator drugs, according to a press release. Dosage is a 10 mg table taken twice daily, approximately 12 hours apart.

 When Ampyra becomes available, it will be distributed exclusively through a network of specialty pharmacies and coordinated by AMPYRA Patient Support Services. Insurance coverage will depend on individual insurance plans.

 For more information, AMPYRA Patient Support Services can be reached at (888) 881-1918.



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