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).
“We are very proud to announce the approval of AMPYRA™ and we
thank Elan for their collaboration throughout the development program
for this drug. Elan’s expertise in formulation development, which
resulted in this extended-release tablet, was a critical component of
the AMPYRA™ clinical program”
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.
“We wish to congratulate Acorda Therapeutics on the approval of AMPYRA™,
which will bring a very important and much needed therapy to the market
for MS sufferers,” announced Shane Cooke, Executive Vice President and
Head of Elan Drug Technologies. “This is the second product on which we
have worked with Acorda and represents another significant milestone in
our successful collaboration with them. It also marks the second product
approved by the FDA in the last six months incorporating our
technologies and reinforces our position of leadership in drug delivery.”