“A significant event”: CBD-based pharma drug Epidiolex presented to FDA for approval

A CBD-based pharmaceutical drug in development is one more step closer to potential FDA approval.

Earlier this week, London-based GW Pharmaceuticals plc, which operates in the United States as Greenwich Biosciences, wrapped up its New Drug Application for Epidiolex, a formulation of the cannabis compound cannabidiol (CBD) for the treatment of seizures associated with two specific types of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

“The submission is a significant event,” said Steve Schultz, a GW spokesman.

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GW Pharmaceuticals’ Epidiolex, a medicine made from cannabis containing cannabidiol (CBD), is shown in New York. (Kathy Young, Associated Press)

The Epidiolex submission file was “thousands of documents” thick, encompassing data and details spanning the areas such as preclinical, clinical, manufacturing and distribution, he said. The submission includes clinical data on

... read more at: http://www.thecannabist.co/2017/11/03/cbd-epidiolex-fda-nda-gw-pharmaceuticals-pharmaceutical-drug/91562/

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