Zogenix, Inc. announced that it has completed enrollment for, and randomized the last patient into the treatment period of, Study 1601, the Company’s Phase 3 clinical trial of its lead investigational therapy, FINTEPLA® (ZX008, fenfluramine), for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), a severe and often treatment-resistant childhood-onset epilepsy.
“We have been extremely pleased with the rate of enrollment in this trial and look forward to the availability of top-line safety and efficacy data in the first quarter of 2020,” said Gail M. Farfel, PhD, Executive Vice President and Chief Development Officer of Zogenix. “Based on the compelling data generated in the previously completed Phase 2 study, we believe this promising drug candidate has the potential to become an important new treatment option for the control of seizures in patients suffering from LGS.”
FINTEPLA for the treatment of LGS has previously been designated as an orphan drug by both the FDA and the European Medicines Agency.