Epidiolex® (cannabidiol; GW Pharmaceuticals) oral solution is no longer a controlled substance, according to the Drug Enforcement Administration (DEA).
The highly purified, plant-derived cannabidiol product is currently approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients ≥2 years old. Shortly after approval, Epidiolex had been placed in Schedule V of the Controlled Substances Act.
Descheduling means that all federal controlled substance restrictions have been removed for the treatment. Once the process is completed in each state, prescriptions for Epidiolex will be valid for 1 year and can be easily transferred between pharmacies. Physicians will also be able to prescribe the treatment without the requirements of state prescription drug monitoring programs.
“We would like to thank the DEA for confirming the noncontrolled status of this medicine,” said Justin Gover, GW’s CEO. “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.”
Recently, the Company announced that the supplemental New Drug Application for Epidiolex to treat seizures associated with tuberous sclerosis complex (TSC) was accepted for priority review by the Food and Drug Administration.
Epidiolex is marketed in the US by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals.
For more information visit gwpharm.com.