Epidiolex® (cannabidiol) oral solution is no longer a controlled substance
Epidiolex oral solution ‒ the only cannabidiol (CBD) prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat epilepsy ‒ is no longer considered a controlled substance under the federal Controlled Substances Act. After reviewing a post-approval supplement submitted by its manufacturer, GW Pharmaceuticals plc (GW), the U.S. Drug Enforcement Administration (DEA) removed the Schedule V designation, as of April 6, 2020.
GW is working on implementing these changes at the state level. Once these changes are in place, prescriptions for Epidiolex will be valid for one year and can be transferred from one pharmacy to another, similar to other non-controlled prescription medications. In addition, Epidiolex is no longer subject to the requirements of state prescription drug monitoring programs.
Usage and safety information
Epidiolex is the first in a new class of anticonvulsants indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older. Although cannabidiol is a derivative of marijuana, it does not cause the same euphoric effects as marijuana. According to GW, removing the Schedule V designation allows for easier access to those living with two of the most debilitating forms of epilepsy. The FDA approved Epidiolex in September 2018. It is not
FDA-approved to treat pain.
Impact on workers’ compensation and auto no-fault
In the fourth quarter of 2018, shortly after its approval by the FDA, the Optum Workers’ Comp and Auto No-fault Pharmacy and Therapeutics (P&T) Committee reviewed Epidiolex to determine its formulary status. Because there is no literature supporting off-label use of Epidiolex for the treatment of any type of pain or injury-related conditions, the P&T Committee voted to exclude Epidiolex on all Optum standard formularies. Furthermore, Epidiolex is designated as a specialty medication and can only be obtained from select specialty pharmacies.
Epidiolex is marketed in the U.S. by Greenwich Biosciences, a subsidiary of GW. To learn more about Epidiolex, please click here.
If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.
- GW Pharmaceuticals plc Press Release. GW Pharmaceuticals plc and Its U.S. Subsidiary Greenwich Biosciences, Inc. Announce That EPIDIOLEX® (cannabidiol) Oral Solution Has Been Descheduled And Is No Longer A Controlled Substance. April 6, 2020. Available at: http://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-plc-and-its-us-subsidiary-greenwich-1.