(Posted By: Josi Creek)
Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA™ will be marketed in the U.S. by Acorda Therapeutics (NASDAQ: ACOR).
Using Elan Drug Technologies MXDAS™ technology, AMPYRA™ was developed using a hydrophilic matrix, which controlled 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. AMPYRA™ is the first New Drug Application (NDA) approved by the FDA for a product using the MXDAS™ technology.
Read the full story here.