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Zogenix Provides Corporate Update and Reports Third Quarter 2021 Financial Results November 4 , 2021 • FINTEPLA® net product sales of $ 21.4 million and total revenue of $ 22.6 million in the third quarter , representing quarter - over - quarter increases of 22 % and 20 % , respectively • Submitted supplemental New Drug Application ( SNDA ) to the U.S. Food and Drug Administration ( FDA ) for FINTEPLA in Lennox - Gastaut Syndrome ( LGS ) • Continuing to advance late - stage development programs for FINTEPLA and MT1621 EMERYVILLE , Calif . , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) -- Zogenix ( NASDAQ : ZGNX ) , a global biopharmaceutical company developing rare disease therapies , today announced financial results for the three and nine months ended September 30 , 2021 , and provided a corporate update . The Company will host a conference call today , Thursday , November 4 , at 4:30 PM Eastern Time / 1 : 30 PM Pacific Time . " In the third quarter , we made significant progress against our corporate objectives in commercial operations and late - stage clinical development programs . We are pleased with the ongoing launch of FINTEPLA in the U.S. and EU and are encouraged with the positive trends that support continued adoption in Dravet syndrome . With the sNDA submitted for LGS , we are moving forward with regulatory submissions for LGS in the EU and a J - NDA in Japan for Dravet syndrome by the end of the year . We are excited to have the opportunity to potentially serve more patients who could benefit from FINTEPLA , " said Stephen J. Farr , Ph.D. , President and CEO of Zogenix . " Concurrently , we are advancing our late - stage development pipeline , notably our global Phase 3 study of FINTEPLA in CDD and concluding studies of MT1621 for the treatment of Tk2 deficiency , " concluded Dr. Farr . Corporate Update • FINTEPLA for the treatment of seizures associated with Dravet syndrome : o As of September 30 , 2021 , the total number of unique prescribers was 334 o As of September 30 , 2021 , over 990 patients in the U.S. were prescribed FINTEPLA and referred to the REMS program o Continuing momentum and increasing adoption of FINTEPLA among prescribers and patients in ongoing launch in Germany and Temporary Authorization of Use in France o Continuing to pursue country - by - country reimbursement in Europe o Zogenix Access Program is now providing FINTEPLA to patients in 8 countries where the therapy is not yet commercially reimbursed o On track for submission of an NDA in Japan ( J - NDA ) to Japan's Pharmaceutical and Medical Devices Agency by the end of 2021 ; received Orphan Drug Designation from the Japanese Ministry of Health , Labour & Welfare • FINTEPLA for the treatment of seizures associated with Lennox - Gastaut syndrome ( LGS ) : • Submitted a supplemental NDA ( SNDA ) to the FDA in late September o Presented data from the interim analysis of its ongoing 12 - month Phase 3 open - label extension study of FINTEPLA in LGS at the Child Neurology 2021 Annual Meeting ; the results demonstrate that treatment with FINTEPLA resulted in highly statistically significant improvements in drop seizure frequency • Median reduction in drop seizure frequency was 39.4 % at 3 months ( n = 247 ; p < 0.0001 ) and 51.8 % for patients assessed over months 10 to 12 ( n = 170 ; p < 0.0001 ) • Of the 170 patients assessed in this analysis , most ( 51.2 % ) responded with a clinically meaningful ( ≥50 % ) reduction in drop seizures , while 25.3 % of patients demonstrated a profound ( ≥75 % ) reduction o Expect to submit type II variation application to Marketing Authorization in EU for approval of LGS indication in fourth quarter of 2021 o Initiated preparations for potential U.S. commercial launch for FINTEPLA in LGS as early as first half of 2022 • FINTEPLA for the treatment of seizures associated with CDKL5 deficiency disorder ( CDD ) : o On track to initiate two - arm , fixed - dose Phase 3 trial to investigate the efficacy and safety of FINTEPLA in controlling convulsive seizure frequency at a dose of 0.7 mg / kg / day in fourth quarter of 2021