On April 6, 2020, the U.S. Drug Enforcement Agency (“DEA”) made history by descheduling Epidiolex, GW Pharmaceuticals’ anti-epileptic oral solution containing cannabiodiol (“CBD”), thereby removing it from the purview of the Controlled Substances Act (“CSA”) even though it is derived from cannabis and not hemp. The DEA’s recent descheduling continues the federal government’s trend of keeping the whole cannabis plant illegal as a Schedule I, while permitting pharmaceutical derivations of cannabis. The DEA’s action on Monday is effective immediately.
The FDA’s approval, which was the first approved medication to contain a purified form of CBD derived from cannabis, originally placed the prescription medication in “Schedule V,” the least restrictive drug rating under the CSA but still rife with restrictions. The DEA’s action comes after GW Pharmaceuticals filed a post-approval supplement with the FDA to remove the Schedule V designation.
This descheduling means enhanced patient access to the drug. More specifically, prescriptions for Epidiolex will be valid for a full year and can be easily transferred between pharmacies. Additionally, deschedueling will enable physicians to prescribe the medicine free of the requirements of state prescription drug monitoring programs. This may equate to insurers having more of an appetite to cover cost as a valid prescription and more pharmacies regularly stocking the product.
The U.S. Food & Drug Administration (“FDA”) previously approved Epidiolex in June 2018 for use for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
As an interesting side note, in February 2020, GW Pharmaceuticals and its subsidiary Greenwich Biosciences Inc. submitted a supplemental New Drug Application seeking an expanded indication for the treatment of seizures associated with tuberous sclerosis complex. This application has been accepted for priority review by the FDA.