Typically, the FDA requires two adequate and well-controlled studies to establish substantial evidence of effectiveness.
In September 2006, Acorda said the drug improved the walking speed in significantly more patients than placebo in a previous trial. With the additional trial the company intends to determine the effectiveness of Fampridine-SR and expects that the trial will be the same or shorter duration than the first phase III study.
Acorda said it would continue to consult with the FDA on protocol development for both of these studies and any additional requirements that might be needed.