Our lead investigational product candidate is ZX008, a low-dose fenfluramine liquid solution for the treatment of Dravet syndrome. Dravet syndrome is a rare and catastrophic form of epilepsy that begins in infancy, with life threatening consequences for patients and for which current treatment options are very limited. ZX008 has received orphan drug designation in the United States and Europe.
For more information about the ZX008 Clinical Studies Program, click here or contact Medical Affairs at: firstname.lastname@example.org.
Zogenix International, Ltd. owns the exclusive license to long-term data and the global intellectual property on the use of low-dose fenfluramine for the treatment of Dravet Syndrome. We initiated Phase 3 clinical studies for ZX008 in the first quarter of 2016.
There are estimated to be between 16,000 and 29,000 patients living with Dravet syndrome in the US and Europe.1 Most of these patients are managed by pediatric epilepsy specialists practicing in approximately 75 specialty treatment centers in the US, with a similar number of centers in Europe.
Children with Dravet syndrome experience severe, long-lasting, fever-related seizures in the first year of life, with other seizure types typically starting over the next several years. These seizures do not respond to standard anti-epileptic medications and often times result in cognitive and developmental impairment, and can be fatal. Currently, polypharmacy with currently available anticonvulsant medications is the standard-of-care but outcomes remain poor as there are no effective, long-term treatments.
Under a Belgian government-sanctioned compassionate use program, low-dose fenfluramine has been used to treat patients with Dravet syndrome in a long-term, open-label study in Belgium for over two decades. For the latest data analysis from this study, please refer to the presentation authored by the lead study clinicians.
We have several patents pending for the use of fenfluramine in Dravet syndrome including elements of a future Risk Evaluation and Mitigation Strategy (REMS) program.2
Zogenix is committed to helping Dravet syndrome patients and their families. In addition to working on the development of a new treatment for this condition, we are actively supporting patient groups such as the Dravet Syndrome Foundation and The Dravet Syndrome European Federation (DSEF) which is a non-profit organization dedicated to aggressively raising research funds for Dravet syndrome and providing support to affected individuals and families, and funding independent research. For more information about Dravet syndrome and the foundation's activities, please go to www.DravetFoundation.org and http://dravet.eu.
- Calculated by patient incidence rates and populations in the US, UK, Germany, Italy, Spain and France.
- Method for the treatment of Dravet syndrome – (13/887,014), (EP 2014/05895), (14/447/253), (14/447/303), (14,447,369)