Epidiolex, a cannabis-derived product approved earlier this year by the Food and Drug Administration for the treatment of childhood seizure syndromes, has been reclassified by the Drug Enforcement Administration. This paves the way for the manufacturer to begin marketing Epidiolex, which is expected to be on the market within 6 weeks.
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GW Pharmaceuticals, in a Sept. 27 press release announcing the rescheduling of the company’s oral cannabidiol (CBD) solution, said that .
The final rescheduling order from the DEA is limited to drugs approved by the FDA that contain cannabis-derived CBD and no more than 0.1% tetrahydrocannabinols. In practice, this means that the rescheduling currently applies only to Epidiolex, since this is the only formulation of CBD that has received FDA approval.
“We are pleased that the DEA has placed Epidiolex in the lowest restriction schedule, because it will help ensure that patients with LGS [Lennox-Gastaut syndrome] and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Pharmaceutical’s chief executive officer Justin Gover in a statement from the company announcing the reclassification.
During the FDA advisory committee meeting for the approval of Epidiolex to treat LGS and Dravet syndromes, both the FDA and GW Pharmaceuticals assessed the abuse potential for CBD as very low, since it does not contain tetrahydrocannabinol, the primary psychoactive component of cannabis.
All other marijuana products are currently classified as schedule I drugs, along with such illegal substances as heroin and cocaine.
Epidiolex had received fast track and rare pediatric designations from the FDA for LGS and Dravet syndrome; the approval was based on three pivotal randomized, double-blind, placebo-controlled clinical trials. The drug met its primary endpoint of reduced seizure frequency in all trials when added to standard of care for patients with drug-resistant LGS and Dravet syndrome.
Safety evaluations assessed data from 1,756 patients, finding that the 20 deaths seen during the study period were not clearly linked to Epidiolex and not unexpected for children with severe seizure disorders.
In supplementary information accompanying the order, the DEA’s acting administrator, Uttam Dhillon, noted that the FDA’s approval of Epidiolex means that “it has a currently accepted medical use in treatment for purposes of the CSA [Controlled Substances Act]. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.” Schedule I drugs, by definition, do not have a currently accepted medical use.
Schedule V drugs, according to the DEA’s website, are currently defined as “drugs with lower potential for abuse than schedule IV and consist of preparations containing limited quantities of certain narcotics.” Other schedule V drugs include cough medicine with less than 200 mg of codeine/100 mL, antidiarrheal medications, pregabalin (Lyrica), and the antiepileptics brivaracetam (Briviact) and lacosamide (Vimpat). “Schedule V drugs represents the least potential for abuse,” according to the website.
Epidiolex is indicated for adjunctive treatment of seizures in patients with LGS or Dravet syndrome aged 2 years and older. Initial dosing recommendations are to titrate to a dose of 10 mg/kg/day, with dose adjustments permissible up to 20 mg/kg/day depending on clinical response and tolerability. The manufacturer has also submitted a marketing agreement to the European Medicines Agency and has received orphan drug designation for Epidiolex in the treatment of another seizure disorder, tuberous sclerosis complex.