Epidiolex is the first FDA-approved treatment in the U.S. that contains a purified drug substance derived from marijuana -- CBD -- and the first treatment for Dravet syndrome. In September 2018 the FDA rescheduled cannabidiol from a C-I controlled substance to a C-V controlled substance, meaning it has a proven medical use but a low risk of abuse. This change allows Epidiolex to be marketed in the U.S.
Typically, pharmaceutical companies making cannabis-based medicines have sought to isolate individual compounds from the plant. But Mechoulam strongly suspects that in some cases those chemicals would work much better in concert with other compounds found in marijuana. He calls this the entourage effect, and it’s just one of the many cannabis mysteries that he says require further study.
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