The Drug Enforcement Administration announced the rescheduling today of Epidiolex, the first FDA-approved medication derived from the cannabis plant, from Schedule 1 to Schedule 5 under the Controlled Substances Act, CNBC reports.
The move paves the way for United Kingdom-based GW Pharmaceuticals, who manufactures Epixiolex, to begin distributing its new CBD epilepsy medication throughout the U.S.
“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.” — Justin Gover, CEO of GW Pharmaceuticals, in a statement
Specifically, the rescheduling applies to CBD that exists in FDA-approved medications; it does not broadly apply to the CBD cannabinoid in all of its forms.
Shares in GW Pharmaceuticals rose 7 percent following news of Epidiolex’s rescheduling.
Epidiolex — an oral solution containing isolated, purified CBD — was approved by the FDA in June. A report in August determined that patients taking Epixiolex can expect to spend about $32,000 per year on the medication.
Early responses to Epidiolex have been positive, and research continues to point to CBD as a largely untapped medicinal resource.