Benzinga | Sep 28, 2021 08:02AM EDT

Zogenix Reports Submission Of Supplemental New Drug Application For FINTEPLA For Treatment Of Seizures Associated With Lennox-Gastaut Syndrome

* Supplemental New Drug Application (sNDA) submission is supported by existing clinical data, including positive data from Company's Phase 3 trial, Study 1601, in which the primary endpoint was met with high statistical significance.

* Lennox-Gastaut Syndrome (LGS) is estimated to affect approximately 30,000-50,000 patients in the U.S.¹

EMERYVILLE, Calif., Sept. 28, 2021 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it has submitted a supplemental New Drug Application (sNDA) for FINTEPLA(r) (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) to the U.S. Food and Drug Administration (FDA).

"As LGS is a severe, rare form of epilepsy that is not well-controlled by currently available anti-seizure medications, we believe that FINTEPLA, if approved, would become an important new treatment option that addresses a significant unmet need for this patient population," said Gail Farfel, Ph.D., Executive Vice President and Chief Development Officer of Zogenix. "We would like to thank the LGS patients, families, and healthcare providers who worked tirelessly alongside us to achieve this milestone in FINTEPLA's development. We appreciate the FDA's guidance through the submission process and look forward to continuing to work closely with the Agency during their review of our application."

The sNDA 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.

LGS is a rare and highly refractory form of childhood-onset epilepsy that is difficult to treat. Patients suffer from significant intellectual, behavioral, and motor disabilities, and have a high risk of status epilepticus or sudden unexpected death in epilepsy. There are an estimated 30,000-50,000 LGS patients in the U.S.¹ The vast majority of patients do not have well-controlled seizures, despite a regimen of two to five antiepileptic drugs¹.

FINTEPLA is approved by the FDA and European Commission for the treatment of seizures associated with Dravet syndrome, a rare infant- and childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, in patients 2 years of age and older. The Japanese Ministry of Health, Labour & Welfare (MHLW) has also granted Orphan Drug Designation to FINTEPLA for the treatment of seizures associated with Dravet syndrome, which Zogenix is developing in Japan.