WASHINGTON, DC — Representatives of the US Food and Drug Administration will undertake a ‘priority review‘ of data specific to the safety and efficacy of Epidiolex, a standardized, plant-derived CBD extract formulated by a British pharmaceutical company.
The review is scheduled to be completed by June 27, 2018.
Phase III clinical trial data shows that Epidiolex administration reduces seizure frequency in various hard-to-treat conditions, such as Lennox-Gastaut syndrome and Dravet syndrome.
To date, the FDA has approved three marijuana-based pharmaceuticals – dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid dronabinol (aka Syndros). All three of these products primarily consist of synthetic forms of THC.
If Epidiolex achieves FDA-approval, analysts suggest the product could retail for between $30,000 to $60,000 annually.
Tags: Epidiolex, FDA, Food and Drug Administration
