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

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.

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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.

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If Epidiolex achieves FDA-approval, analysts suggest the product could retail for between $30,000 to $60,000 annually.

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