AmpyraTreatment for Multiple Sclerosis
Update: Ampyra (formerly Fampridine-SR) Now FDA Approved - January 22, 2010
Refuse to File Letter from FDA for Fampridine-SR NDA
Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA
HAWTHORNE, N.Y.-- Mar 31, 2009 - Acorda Therapeutics, Inc. announced today that the Company received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).
The FDA has raised what it termed "format issues" regarding the eCTD (electronic) submission, requesting that some of the data in the NDA be reformatted, as well as requesting that some additional supporting information be included in the filing. The FDA has not requested or recommended additional clinical or other studies.
"We are surprised by this development," stated Ron Cohen, M.D., President and CEO of Acorda Therapeutics, "We plan to address the issues raised in this letter with FDA expeditiously as we believe Fampridine-SR is potentially an important, first in class treatment option for people suffering with MS."
The Company plans to request a meeting with FDA as soon as possible to discuss its comments on the NDA filing.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex Capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact: Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
Posted: March 2009
- FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis - January 22, 2010
- Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010 - October 22, 2009
- Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR - October 14, 2009
- Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS - August 25, 2009
- Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing - May 6, 2009
- Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis - April 23, 2009
- Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis - February 2, 2009