Q&A on the DEA Rescheduling of Epidiolex

questions and answers

Epilepsy News From:

Tuesday, October 2, 2018

How are drugs classified or “scheduled” in the United States?

The U.S. Food and Drug Administration (FDA) oversees drugs in the United States. In 1970, the FDA released drug classifications or drug schedules, under the Controlled Substance Act (CSA). The drug classification schedules organize drugs into five groups. Drugs are scheduled as Class I, II, III, IV, or V.

What is a drug schedule?

Drugs and other substances that are considered controlled substances under the CSA are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.

  • U.S. Drug Enforcement Administration (DEA) Schedule I drugs have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.
  • Schedule V drugs have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
  • Examples of Schedule V drugs are many cough preparations with less than 200 milligrams of codeine per 100 milliliters (Robitussin AC) or Lomotil. Lyrica, Brivact, and Vimpat are examples of Schedule V anti-seizure medications.

When is a drug rescheduled by the DEA?

The DEA routinely reschedules medications as they are approved for use by the FDA.

How does rescheduling apply to Epidiolex®?

  • On September 27, 2018, the DEA rescheduled Epidiolex, the plant-based, purified cannabidiol (CBD) oil.
  • The DEA did not reschedule all cannabidiol products or other products claiming to contain CBD.
  • The DEA schedule for Epidiolex is Schedule V.

Why did the DEA reschedule Epidiolex?

The DEA had to reschedule Epidiolex as it was approved by the FDA in June 2018 for the treatment of Dravet syndrome and Lennox-Gastaut syndrome in people two years of age and older. This allows medical providers anywhere in the United States to be able to prescribe Epidiolex once their state determines whether to agree with this schedule or a similar one.

Does the rescheduling apply to marijuana or other CBD products?

Marijuana (cannabis) is considered a Schedule I drug, which it defines as having no currently accepted medical use and a high potential for abuse. Because CBD is a compound found in the marijuana plant, it is considered a Schedule I drug and therefore illegal. However, this plant-based product showed medical benefit and a low potential for abuse in several studies.

The new rescheduling applies to CBD containing no more than 0.1 percent tetrahydrocannabinol (THC) in FDA-approved drug products.

The change in scheduling by the DEA does not broadly apply to marijuana, CBD products, or oils. The FDA was clear to distinguish that Epidiolex contains purified CBD, and the agency's decision was not a broad approval of the substance. Commissioner Scott Gottlieb said the FDA remains "concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims."

When will Epidiolex be available for use?

Greenwich Biosciences (the U.S. based company of GW Pharmaceuticals) has communicated that it would "work hard" to make Epidiolex available within the next six weeks or so for providers to prescribe.

Authored by: Anup Patel MD on 10/2018
Reviewed by: Elaine Kiriakopoulos MD, MSc | MD | MSc | Joseph I. Sirven MD on 10/2018

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