Zogenix announced that it has submitted its Type II Variation Market Authorization Application to the European Medicines Agency (EMA) for FINTEPLA® for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a highly treatment-resistant form of childhood-onset epilepsy. If approved, the application would expand the use of FINTEPLA in Europe beyond Dravet syndrome to include LGS. The EMA submission for FINTEPLA is supported by data from a global randomized, placebo-controlled Phase 3 clinical trial Study 1601 in 263 patients (age 2-35 years) that demonstrated FINTEPLA at a dose of 0.7/mg/kg/day was superior to placebo in reducing the frequency of drop seizures (p=0.0012). The same dose of FINTEPLA (0.7 mg/kg/day) also demonstrated statistically significant improvement versus placebo in the key secondary efficacy measure, the proportion of patients with a clinically meaningful reduction (=50%) in drop seizure frequency. The submission also includes long-term safety and effectiveness data from Zogenix’s on-going open-label extension trials. FINTEPLA has been generally well-tolerated, with the adverse events observed to date consistent with those observed in the Company’s prior Phase 3 studies in Dravet syndrome.