Epidiolex received approval from the Food and Drug Administration (FDA) earlier this year but the Drug Enforcement Agency (DEA)’s decision was the last barrier to reaching patients with Lennox-Gastaut and Dravet syndrome.
With Epidiolex containing an active ingredient produced by the cannabis plant, it was a regulatory grey area whether the drug would be able to reach patients.
Under DEA scheduling, cannabis is listed as a Schedule I drug – which states that the drug has no accepted medical use and a high potential for abuse. The DEA decided that Epidiolex would be marked as a schedule V drug.
However, in its press release on the matter, the DEA made clear that this is an exceptional case and has no impact on the scheduling for cannabis and broader cannabidiol (CBD) products: “Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit. In those instances, such as here, the drug will be made appropriately available to the public for medical use.”
GW Pharmaceuticals revealed that the DEA’s decision would see the product made available within six weeks.
The Epilepsy Foundation welcomed the news, releasing a statement reading: “The DEA's rescheduling of Epidiolex, the first-ever drug derived from CBD approved to treat Dravet and Lennox-Gastaut syndromes, is a tremendous milestone for some of these most vulnerable individuals who now may have access and hope of gaining better seizure control.”
GW Pharma plans to expand the range of indications that Epidiolex holds to treat such as diseases as tuberous sclerosis complex. Analysts predict the drug will be a financial success for the company, with a global peak sales prediction of over $1bn (€862m) by 2026.