Zogenix

Zogenix develops and commercializes central nervous system (CNS) therapies that address specific clinical needs for people with orphan and other CNS disorders. Zogenix’s primary focus is epilepsy and related seizures disorders.

Zogenix announced in 2019 its intention to resubmit its New Drug Application for FINTEPLA (ZX008, fenfluramine) with agreement from the FDA, later that year for treatment of seizures associated with Dravet syndrome. Issues in a previous FDA Refusal to File letter were addressed. The FDA has separately rescinded FINTEPLA for treatment of seizures associated with Dravet syndrome due to it no longer meeting administrative criteria for designation as there are two approved therapies for the disease. In clinical trials, comparisons were not made with the recently approved cannabidiol since it was an investigational product at the time. FINTEPLA has been accepted for review by the European Medicines Agency and is in development in Japan. The drug is being evaluated in a multi-national Phase 3 clinical trial for treatment of seizures associated with Lennox-Gastaut Syndrome. Fenfluramine is an amphetamine derivative and was originally approved as an appetite suppressant and stimulates release of serotonin from vesicular storage and modulated serotonin transporter function.

Relday (risperidone once-monthly long-acting injectable) is a product candidate for the treatment of schizophrenia. Rishperidone is used to treat symptoms of schizophrenia and bipolar disorder in adults and teenagers. Relday is a long-acting injectable form of risperidone and it has completed Phase I clinical studies as of 2019.