Acorda Therapeutics Inc.tried out a more traditional design in a post-market trial of Ampyra (dalfampridine), its drug for improving walking ability in multiple sclerosis, as requested by FDA, but neither the approved 10 mg dose nor a lower 5 mg dose met the study’s primary endpoint.
FDA approved a 10 mg twice-daily dose of Ampyra in January 2010. Supporting the first approval for improvement in walking...