The U.S. Food & Drug Administration (FDA) approved Epidiolex®, the first ever drug derived from cannabidiol (CBD), on June 25, 2018. Once approved by the FDA, the Drug Enforcement Administration (DEA) had 90 days to act since CBD is a Schedule I substance. On September 27, 2018, the DEA rescheduled Epidiolex® as a Schedule V substance, which is in line with the FDA's recommendation and is a big win for the epilepsy community. Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of limited quantities of certain narcotics which are known to cause dependency. Epidiolex® is approved for the treatment of Dravet and Lennox-Gastaut syndromes (LGS).
Dravet syndrome is a rare and catastrophic form of intractable epilepsy that begins in infancy and is highly treatment-resistant. It is a debilitating, life-long condition characterized by frequent and prolonged seizures, poor seizure control, and developmental delays, as well as an increased risk of premature death including sudden unexpected death in epilepsy (SUDEP). Lennox-Gastaut syndrome (LGS) is a rare and often debilitating form of childhood-onset epilepsy that is highly treatment-resistant. It is characterized by multiple seizure types, and moderate to severe cognitive impairment. Individuals living with Lennox-Gastaut syndrome experience an increased risk of serious injury because of frequent falls associated with uncontrolled seizures.
Since CBD is a Schedule I substance under most state schedules, state action is needed to ensure proper rescheduling of FDA-approved treatments derived from CBD. Unless states act to ensure access to new treatments derived from CBD that are approved by FDA and scheduled by DEA, these therapies will not be made available to individuals living with uncontrolled seizures. Therefore, we will continue to advocate in states where legislation is necessary to create a pathway for therapies derived from CBD for this medication and any future medications.