The Drug Enforcement Administration has rescheduled Epidiolex, paving the way GW Pharmaceuticals to start selling the first FDA-approved drug that’s derived from cannabis, but stopping short of reclassifying all cannabidiol products.
The Food and Drug Administration in June approved Epidiolex, which is derived from cannabidiol, or CBD, a molecule contained in the marijuana plant. This forced the DEA to consider how it would classify Epidiolex since marijuana is considered a schedule 1 drug, which it defines as having no currently accepted medical use and a high potential for abuse.
Epidiolex will be classified as a schedule 5 controlled substance, the lowest level, defined as those with a proven medical use and low potential for abuse. Other drugs in this category include some cough medicines containing codeine.
The drug is indicated to treat patients two years and older with Dravet Syndrome and Lennox-Gastaut Syndrome, rare forms of epilepsy that emerge during childhood and can be difficult to treat. It does not contain tetrahydrocannabinol, or THC, the psychoactive compound in cannabis that makes people high.
GW Pharma said it would “work hard” to make Epidiolex available within the next six weeks. Shares of GW Pharma rose 7 percent on the news.
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