Catalyst Pharma Meets Primary Endpoint For Cardiac Safety In Firdapse Evaluation

(RTTNews) - Catalyst Pharmaceutical Partners, Inc. (CPRX) Wednesday said its study to assess the cardiac safety of Firdapse tablets met its primary endpoint, with no effect on heart rate or cardiac depolarization at and above therapeutic levels when administered as phosphate salt. Further, the first formal human evaluation has not recorded clinically relevant electrocardiographic/morphological changes following administration of Firdapse. The company also noted that there was no significant effect of Firdapse on cardiac repolarization as assessed using the QT interval.

According to Charles Gorodetzky, chief medical officer for Catalyst, Firdapse did not lead to QT prolongation, even at high concentrations in the blood.

The study was jointly conducted by BioMarin Pharmaceuticals (BMRN). Firdapse, which was approved in the European Union, is currently in Phase 3 development in the U.S. for Lambert-Eaton Myasthenic Syndrome by Catalyst.