The Drug Enforcement Administration is placing Epidiolex in Schedule V, the least restrictive of the Controlled Substances Act
The Drug Enforcement Agency (DEA) is placing Epidiolex in Schedule V, the least restrictive schedule of the Controlled Substances Act.1
The drug is an oral solution containing cannabidiol (CBD), a chemical constituent of the cannabis plant, and it is expected to arrive on the market within 6 weeks.2
Previously classified as Schedule I,3 Epidiolex was approved in June to treat seizures associated with 2 rare and severe forms of epilepsy—Dravet syndrome and Lennox-Gastaut syndrome (LGS)—in patients aged 2 years and older.1-2 Manufactured by GW Pharmaceuticals and its US subsidiary Greenwich Biosciences, Epidiolex was the first product containing a purified drug substance derived from marijuana that the FDA approved for medical use.
CBD does not cause intoxication or the euphoria that comes from tetrahydrocannabinol, the primary psychoactive component of marijuana.3
Thursday’s announcement by the DEA marked the “final step” of the regulatory process for Epidiolex.
The placement of Epidiolex in Schedule V allows the company to move forward with making the product available to the market, according to Justin Gover, chief executive officer of GW Pharmaceuticals.2
“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, 2 of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” he said in a statement.2 “We know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA.”
Prior to receiving FDA approval, the Epidiolex clinical development program included 3 randomized, controlled Phase 3 clinical trials and an open-label extension study. The Phase 3 studies showed that Epidiolex added to other antiepileptic therapies, significantly reducing the frequency of seizures in patients with Dravet syndrome and LGS.4
“Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients,” FDA Commissioner Scott Gottlieb said in a statement.3 “Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes."
The most common adverse reactions that occurred in patients treated with Epidiolex were somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, asthenia, rash, insomnia, sleep disorder and poor-quality sleep, and infections, according to GW Pharmaceuticals.4
In a statement, Acting DEA Administrator Uttam Dhillion said that the agency is committed to working with federal partners in seeking ways to make the pharmaceutical research process more effective and efficient.
“DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” he said.1
CBD and marijuana derived from marijuana remain illegal, with the exception of limited circumstances in which it has been determined to have a medically approved benefit. In those cases, including Epidiolex, the drug will be made appropriately available to the public for medical use, according to the DEA.1
Medicines in Schedule V have a low potential for abuse and a proven medical use. The DEA’s decision to move Epidiolex to Schedule V was based on clinical and non-clinical that evaluated the medicine’s potential for abuse and applies only to CBD products approved by the FDA. Other, non-FDA-approved CBD preparations remain in Schedule I.2