News Release: Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Abil
Posted Nov 17 2009 10:20pm
Peripheral and Central Nervous System Drugs Advisory Committee to Hold Meeting on October 14, 2009
Proposed Trade Name for Fampridine-SR, if approved, is Amaya™
HAWTHORNE, N.Y. --(BUSINESS WIRE)--Aug. 25, 2009-- Acorda Therapeutics, Inc.(Nasdaq: ACOR ) today announced that the U.S. Food and Drug Administration ( FDA ) has confirmed that its Peripheral and Central Nervous System Drugs Advisory Committee will review the Company’s New Drug Application (NDA) for Fampridine-SR on October 14, 2009. The meeting will take place at the Inn and Conference Center, University of Maryland University College (UMUC), Marriott Conference Centers, 3501 University Blvd. East, Adelphi, MD. Information related to the meeting is available on the U.S. Office of the Federal Register web site at: http://edocket.access.gpo.gov/2009/pdf/E9-20380.pdf
The Company also announced that it has received preliminary approval for the proposed trade name Amaya from the FDA.
Fampridine-SR is a novel therapy being studied as a potential treatment to improve walking ability in people with multiple sclerosis. The Fampridine-SR NDA was accepted by the FDA on May 5, 2009 and assigned Priority Review status. At that time, the FDA set a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009; the PDUFA date is the target date for the FDA to complete its review of Fampridine-SR.
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics and manufactured by Elan Corporation plc.