GW Pharmaceuticals’ (GW) cannabidiol (CBD) formulation Epidiolex has cleared the final step in the regulatory approval process and been transferred to the Schedule 5 category where it will reside alongside codeine, opium, and other drugs deemed to have low potential for dependence and abuse and a currently accepted medical use in the United States.
Epidiolex contains less than .1 percent THC and is the first plant-based cannabinoid medicine available by prescription in the United States since before prohibition. The product is intended to treat individuals with LGS and Dravet syndrome, two rare and severe forms of epilepsy that develop in childhood.
The Food and Drug Administration (FDA) approved Epidiolex on June 25, 2018, after GW completed the required clinical trials.
“We are pleased that the DEA has placed EPIDIOLEX in the lowest restriction Schedule,” said GW Chief Executive Officer Justin Gover in a press release. “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,”
While the DEA’s new scheduling will allow physicians to prescribe Epidiolex, it does not apply to the widely-available range of other CBD products which do not have FDA approval and are still considered to be Schedule 1.
Side effects associated with Epidiolex may include decreased appetite, diarrhea, sleep issues, infection, rash, fatigue, and malaise.
GW estimates that Epidiolex will be available by prescription within the next six weeks.