ARTICLE | Clinical News

Catalyst's Firdapse meets in LEMS Phase III

September 30, 2014 2:30 AM UTC

Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX) said its oral potassium channel blocker Firdapse amifampridine met the co-primary endpoints in a Phase III trial to treat Lambert-Eaton myasthenic syndrome (LEMS). In the 38-patient study, Firdapse improved scores vs. placebo on the change in subject global impression and quantitative myasthenia gravis scales (p=0.0028 and p=0.0452, respectively).

Firdapse has breakthrough designation in the U.S., where Catalyst plans to submit a rolling NDA to FDA in early 2015. Catalyst obtained North American rights to Firdapse from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) in 2012. ...