This excerpt taken from the ACOR 8-K filed Dec 8, 2006.
Acorda Therapeutics Provides Update on Clinical Development of Fampridine-SR
HAWTHORNE, NY, December 8, 2006 Acorda Therapeutics, Inc.® (Nasdaq: ACOR) today confirmed that, based on feedback it received in a meeting with the U.S. Food and Drug Administration (FDA), it will design and conduct an additional Phase 3 trial of Fampridine-SR in people with MS. Consistent with that meeting, the company expects to discuss with the FDA a study of the same or shorter duration as its MS-F203 study with a single criterion for efficacy, a consistent response on the Timed 25 Foot Walk.
In September 2006, the Company announced the results of its recent Phase 3 study, MS-F203, which was based on a Special Protocol Assessment (SPA) from the FDA. The FDA indicated that, while this would require confirmation in a New Drug Application (NDA) filing, the criteria for the SPA appear to have been met. Typically, the FDA requires two adequate and well-controlled studies, each convincing on its own, to establish substantial evidence of effectiveness.
Based on the discussion, Acorda also plans to execute a QT study in accordance with the FDAs October 2005 guidance, Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. The Company will continue to consult with the FDA on protocol development for both of these studies and any additional requirements that might be needed.