The US Drug Enforcement Administration (DEA) has descheduled GW Pharmaceuticals’ antiepileptic cannabidiol (CBD) oral solution (Epidiolex), making it no longer subject to the Controlled Substances Act (CSA), the company announced in a press release. This change is effective immediately.
DEA’s letter means that all federal controlled-substance restriction have been removed for the product. Once these changes have been implemented, all prescriptions for CBD oral solution will be valid for 1 year and can be easily transferred between pharmacies. Additionally, these changes will enable physician to prescribe the medicine free of the requirements of state prescription drug monitoring programs.
The CBD oral solution was launched in the United States on November 1, 2018, following approval by the FDA for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older. It is the first approved medication that contains a purified drug derived from marijuana and the first approved treatment for DS. Although the therapy was initially placed in Schedule V of the CSA, GW filed a post-approval supplement with the FDA to remove the Schedule V designation.
Approval was based on data from 3 clinical trials of 516 patients with either LGS or DS. In both LGS and DS, CBD oral solution was associated with a significant reduction in total seizure frequency. In February 2020, GW and its subsidiary Greenwich Biosciences Inc submitted a supplemental New Drug Application seeking an expanded indication for the treatment of seizures associated with tuberous sclerosis complex.
“This notification from the DEA fully establishes that Epidiolex, the only CBD medicine approved by FDA, is no longer controlled substance under the federal Controlled Substances Act,” Justin Gover, chief executive officer of GW, said in a statement. “We would like to thank DEA for confirming the non-controlled status 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.”