FDA Grants ‘Priority Review’ Of Plant-Derived CBD Extract

DISTRICT OF COLUMBIA: 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.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.