Prescription Pharmaceutical Cannibidiol (Epidiolex) No Longer a Controlled Substance

The Drug Enforcement Administration (DEA) has confirmed to the manufacturer that prescription pharmaceutical cannabidiol (ppCBD) (Epidiolex; GW Pharma, Carlsbad CA) has been descheduled. This change takes effect immediately. Approved for treatment of seizures in people with Dravet Syndrome and Lennox-Gastaut Syndrome who are more than age 2 years, ppCBD is no longer subject to the Controlled Substances Act (CSA).

The manufacturer has filed a postapproval supplement with the Food and Drug Administration to remove the previous Schedule V designation from the label. Implementation of these changes at the state level will begin, and once completed in each state, prescriptions for ppCBD, like other noncontrolled medicines, will be valid for 1 year and easily transferred between pharmacies. The descheduling allows physicians to prescribe ppCBD without the requirements of state prescription drug monitoring programs.

“This notification from DEA fully establishes that Epidiolex, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” said Justin Gover, GW’s Chief Executive Officer.  “We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of Epidiolex has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”

Dravet syndrome and Lennox Gastaut syndrome are 2 rare and difficult-to-treat epilepsy syndromes. The first FDA-approved medication derived from the Cannabis plant, ppCBD is the first in a new category of antiseizure medication and is also being studied for the treatment of seizures in tuberous sclerosis complex.