Today, specialty pharmaceutical company Catalyst Pharmaceutical Partners announced that the independent data monitoring committee (DMC) overseeing its ongoing pivotal Phase III clinical trial of Firdapse recommended on March 25 that the company continue the trial as planned based on the committee’s review of safety and clinical data from the trial. Firdapse is currently being evaluated in the United States and Europe to treat Lambert-Easton Myasthenic Syndrome (LEMS).
The DMC is comprised of experts who are responsible for independently reviewing accumulated clinical safety and efficacy data obtained in Catalyst’s clinical trial, for the safety of participants and future patients. The committee considers data that is specific to the study, as well as pertinent background knowledge about the disease, test agent, or patient population being studied.
The Phase III clinical trial of Firdapse is designed as a randomized, double-blind, placebo-controlled discontinuation trial consisting of 30 enrolled patients who have been diagnosed with LEMS. The trial is taking place at sites within the U.S. and Europe. The company plans to add up to 20 more sites in the U.S., Europe, Canada, and South America and anticipates completing enrollment in the trial by the end of 2013’s fourth quarter. Catalyst plans to announce topline data from the trial during the second quarter of 2014.
Catalyst Pharmaceutical Partners is a specialty pharmaceutical company with its focus on developing and commercializing prescription drugs that target rare (orphan) neuromuscular and neurological diseases and disorders, including Lambert-Eaton Myasthenic Syndrome, infantile spasms, and Tourette’s syndrome. Firdapse is the company’s lead candidate.
For more information, visit www.catalystpharma.com
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