Catalyst Pharmaceuticals Announces Publication of Phase 3 Clinical Trial Data for Firdapse® for the Treatment of Lambert-Eaton Myasthenic Syndrome
The positive topline results from this trial were previously announced, but the full results of safety, efficacy, and other clinical data are now available online. The LMS-003 trial was a randomized, double-blind, placebo-controlled design. Both co-primary endpoints were met with statistical significance (QMG score: p=0.0004 and Subject Global Impression Score: p=0.0003). This was further supported by similar success with other endpoints (Triple Timed Up and Go walk test and the Clinical Global Impression of Improvement). The study provided statistically and clinically significant evidence that Firdapse was safe and effective in treating LEMS patients.
These data are more fully described in the manuscript entitled, “Amifampridine Phosphate (Firdapse) Is Effective in a Confirmatory Phase 3 Clinical Trial in LEMS”. The article can be accessed at the
“The results of this second pivotal Phase 3 trial again demonstrate that Firdapse is effective for the treatment of LEMS,” said
Firdapse is currently being evaluated in clinical trials for the treatment of CMS, MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst will be successful in commercializing Firdapse, (ii) whether, even if Catalyst is successful in commercializing Firdapse, Catalyst will become profitable, (iii) whether Firdapse will ever be approved for the treatment of CMS, MuSK-MG, SMA Type 3, or any other disease, and (iv) those other factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2017 and its other filings with the
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Source: Catalyst Pharmaceuticals, Inc.