Acorda Gains Approval for Ampyra

Acorda Therapeutics, Inc. received approval from the FDA for Ampyra (dalfampridine) to improve walking in patients with multiple sclerosis (MS). Ampyra is an extended release tablet formulation of the investigational drug dalfampridine (4-aminopyridine and called fampridine outside the U.S.). Ampyra will be marketed by Acorda Therapeutics, Inc. in the U.S. and Biogen Idec will commercialize fampridine as a prolonged release tablet in markets outside of the U.S.

Ampyra was developed using Elan Drug Technologies MXDAS technology, a hydrophilic matrix that controls the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced.

Biogen Idec submitted a MAA to the EMEA on January 12, 2010 for prolonged release fampridine tablets for the improvement of walking ability in adult patients with MS. The company also has filed a New Drug Submission (NDS) to Health Canada.