ARTICLE | Clinical News

Firdapse amifampridine: Phase III ongoing

January 13, 2014 8:00 AM UTC

Catalyst said that FDA requested a "slight modification" in the analysis of the endpoints of its ongoing double-blind, placebo-controlled, international Phase III trial of Firdapse in about 36 patients. The company said it does not believe the modification will require changes in data collection or the number of patients needed for enrollment. Catalyst said it anticipates meeting previously disclosed timelines for submission of an NDA for Firdapse to treat LEMS. The company previously said it plans to submit an NDA in 1H15. The trial is evaluating Firdapse given 3-4 times daily for a daily dose of 30-80 mg, except in patients with moderate renal impairment, who will receive a starting dose of 10 mg. ...