The U.S. Food & Drug Administration (FDA) approved Epidiolex®, the first ever drug derived from cannabidiol (CBD), on June 25, 2018. The Drug Enforcement Agency (DEA) must now take action to schedule the medication because CBD is a Schedule I substance. 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.