GW Pharmaceuticals plc, a biopharmaceutical company focused on developing and commercializing therapeutics from its proprietary cannabinoid platform, along with its U.S. subsidiary Greenwich Biosciences, Inc., has received notification from the United States Drug Enforcement Administration (DEA) confirming that Epidiolex (cannabidiol) is no longer subject to the Controlled Substances Act (CSA), effective 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 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.”
Epidiolex, which was launched in the United States on Nov. 1, 2018 after approval by FDA for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome in patients two years of age or older, is the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), and the first in a new category of anti-epileptic drugs.
Following FDA approval, Epidiolex was initially placed in Schedule V of the CSA. Following receipt of this DEA notification, GW has filed a post-approval supplement with FDA to remove Schedule V designation from Epidiolex.
DEA’s letter means that all federal controlled-substance restrictions have been removed for Epidiolex. The company will now begin the process of implementing these changes at the state level and through the Epidiolex distribution network. Once this process is completed in each state, prescriptions for Epidiolex, like other non-controlled medicines, will be valid for one year and can be easily transferred between pharmacies. The descheduling of Epidiolex also enables physicians to prescribe this breakthrough medicine free of the requirements of state prescription drug monitoring programs.
The most common adverse reactions that occurred in Epidiolex-treated patients were somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, and asthenia, rash, insomnia, sleep disorder and poor-quality sleep, and infections. The medicine is marketed in the United States by Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals plc.