Cannabis biopharmaceutical company GW Pharmaceuticals today announced that it has received a notification from the United States Drug Enforcement Administration (DEA), confirming that the company’s epilepsy medication, Epidiolex, is no longer subject to the Controlled Substances Act (CSA).
Epidiolex is a cannabidiol (CBD)-based epilepsy treatment aimed at controlling seizures in Dravet syndrome and Lennox-Gastaut Syndrome patients over the age of two.
GW Pharmaceuticals launched Epidiolex in the U.S. in November of 2018 after a lengthy clinical trial process and final approval from FDA.
The medication was initially placed in the Schedule V category of the CSA, but with confirmation from DEA, it is no longer there.
The change goes into effect immediately.
“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 GW Pharmaceuticals CEO Justin Gover. 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.”
After receiving the DEA notification, GW Pharmaceuticals filed a post-approval supplement with the United States Food and Drug Administration to remove Epidiolex’s Schedule V designation there.
With federal controlled substance restrictions removed from Epidiolex, GW Pharmaceuticals will begin implementing changes at the state level and through the medication’s distribution network.
When the process is completed in each state, Epidiolex prescriptions will be valid for a full year and can be transferred between pharmacies.
GW Pharmaceuticals says that the removal of Epidiolex from the CSA allows physicians to prescribe the medication without having to meet the requirements of state prescription drug monitoring programs.