Recently, Acorda Therapeutics Inc. (ACOR) announced that the U.S. Food and Drug Administration (FDA) has cleared its oral drug Ampyra (dalfampridine) which aims to improve walking speed in patients suffering from multiple sclerosis (MS). The company expects to launch the drug in the United States in March 2010. Ampyra is the first drug to get FDA approval for treating walking impairment in MS patients.
Ampyra, previously known as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously referred to as fampridine. The drug enjoys orphan drug designation from the U.S. agency, thereby providing it with seven years of market exclusivity.
Ampyra will be manufactured under a license and supply agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (ELN). However, Ampyra will be marketed and distributed in the U.S. by Acorda.
Ampyra was found to be effective in patients with all four major MS types (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). The drug can either be used alone or with existing treatments for MS, including immunomodulator drugs.
However, the U.S. agency stated that Ampyra can cause seizures if patients take higher-than-recommended doses, and it should be avoided by those suffering from moderate to severe kidney disease. Ampyra is administered orally as a 10 mg tablet twice daily. The tablets should preferably be taken approximately 12 hours apart.
The MS market has big players such as Biogen Idec (BIIB), Pfizer (PFE) and Teva Pharmaceutical Industries (TEVA). MS is a chronic, usually progressive disease which affects the brain and nervous system, resulting in loss of balance, muscle spasms and other movement related problems. More than 400,000 Americans suffer from the disease. MS is estimated to affect 2.5 million people globally.