Zogenix will resubmit its NDA for Fintepla to treat seizures associated with Dravet syndrome in Q3 2019.

Zogenix, Inc.has announced that following receipt of final minutes from the FDA from the Type A meeting held on 30 May 2019, the Company intends to resubmit its New Drug Application (NDA) for Fintepla (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in the third quarter of this year.

The Type A meeting was conducted to review the two issues identified in the Refusal to File (RTF) letter issued by the FDA on 5 April 2019: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset. Based on the final meeting minutes received, the FDA has agreed to Zogenix�s plan to resubmit the NDA for Fintepla without the inclusion of the new chronic toxicity studies requested in the RTF letter. With regards to the second issue, the Company conducted and discussed with the FDA a root cause analysis to explain the incorrect clinical dataset submitted in the original NDA, and the FDA is in agreement with the Company�s plan for resubmission of the datasets in the NDA.

Separately, the FDA has rescinded Breakthrough Therapy Designation for Fintepla for the treatment of seizures associated with Dravet syndrome because there are now two approved therapies for the disease and, therefore, the administrative criteria for designation are no longer met.

The results from the Fintepla clinical program demonstrated that patients adding Fintepla to a stiripentol- based regimen (stiripentol is one of the recently approved treatments) experienced a 54.7% greater reduction in mean monthly convulsive seizure frequency compared to patients adding placebo (p<0.001). however no such comparisons were possible with cannabidiol the second recently approved drug since it was an investigational product at the time the fintepla pivotal trials were conducted and was therefore an excluded treatment. zogenix does not expect the rescission of breakthrough therapy designation to limit the potential for priority review status 6-month review for the companys resubmitted nda.>