[{"orgOrder":0,"company":"Zogenix","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zogenix Announces Positive Top-line Results from Trial of FINTEPLA\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Zogenix","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zogenix Presents New Data from a Study Highlighting the Impact of Treatment with FINTEPLA Oral Solution on Dravet Syndrome Patients","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 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Find Clinical Drug Pipeline Developments & Deals for (+-)-Fenfluramine
FINTEPLA (fenfluramine) is a serotonin releasing agent, and thereby stimulates multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain.
Approval supported by clinical trial data that showed when added to existing treatment regimens, Fintepla (fenfluramine) significantly reduced monthly convulsive seizure frequency compared to placebo.
Primary endpoint was met demonstrating that Fintepla (fenfluramine), as adjunctive treatment, is effective in significantly reducing the frequency of drop seizures in LGS patients compared to placebo.
FINTEPLA® (fenfluramine) oral solution is a prescription medication approved in the U.S. and Europe, and under regulatory review in Japan, for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
FINTEPLA (fenfluramine) is approved by the FDA and European Commission for the treatment of seizures associated with Dravet syndrome and is in development in Japan for the treatment of seizures associated with Dravet syndrome.
The submission is based on the results of Phase 3, which met its primary objective in demonstrating that patients in the FINTEPLA (Fenfluramine) achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to the placebo group.
sNDA is supported by Phase 3 Study 1601 for FINTEPLA® (fenfluramine) for treatment of seizures associated with Lennox-Gastaut Syndrome to FDA. FINTEPLA is approved by the FDA and European Commission for treatment of seizures associated with Dravet syndrome.
Zogenix plans to submit a new drug application (J-NDA) for FINTEPLA in Japan for the treatment of seizures associated with Dravet syndrome by year end.
Across studies, FINTEPLA has been generally well-tolerated, with no observed cases of pulmonary arterial hypertension (PAH) or valvular heart disease (VHD). The most common adverse events were reported as decreased appetite, fatigue, diarrhea, and pyrexia.
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