The Drug Enforcement Administration placed Epidiolex in Schedule V today, marking the first time any drug derived from any part of the cannabis plant has been rescheduled in the U.S.; the drug includes cannabidiol (CBD). Epidiolex was approved by the Food and Drug Administration in June.
This is the only cannabis-derived drug, thus far, that the DEA has rescheduled. "Marijuana extracts," including CBD, remain in Schedule I, according to the administration's 2016 Final Rule.
The news brought an increase in pre-market trading for manufacturer GW Pharma, which trades on the Nasdaq under GWPH. The stock opened Sept. 27 at $169.50.
Justin Glover, CEO of GW Pharma, said in a prepared statement that Epidiolex will be available "within the next six weeks."
“We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” he said.
According to the DEA, "Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes."
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