An experimental cannabis-derived drug has successfully treated children with severe epilepsy in a third late-stage clinical trial, sending shares in Britain's GW Pharmaceuticals to a record high on Monday.
GW, which was founded in 1998 to capitalize on the medical benefits of cannabis, said it now expected to submit a marketing application for Epidiolex to the U.S. Food and Drug Administration in the first half of 2017.
Its multiple sclerosis treatment Sativex, which is sprayed under the tongue, is already distributed by marketing partners in more than 20 countries, but not in the United States.
If Epidiolex is approved, it could become the first U.S.-approved prescription to be extracted from cannabis. It contains cannabidiol, a component of cannabis that does not make people high, and is administered as a child-friendly syrup.