The US Drug Enforcement Administration’s decision to move Epidiolex to Schedule V was based on non-clinical and clinical data that evaluated the medicine’s potential for abuse
GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercialising novel therapeutics from its proprietary cannabinoid product platform has announced that Epidiolex (cannabidiol) oral solution has been transferred to Schedule V, the lowest restriction classification, by the US Drug Enforcement Administration (DEA).
Epidiolex, which was approved by the US Food and Drug Administration (FDA) on 25 June, 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age or older, is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).
“We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said Justin Gover, GW’s CEO.
“With this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next 6 weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA.”
With this decision, the product label for Epidiolex will be finalised. The company’s development programme represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with LGS and Dravet syndrome.
Both diseases, which develop in childhood, are rare, severe forms of epilepsy that are notoriously treatment-resistant. Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to currently approved AEDs.
The day-to-day impact of these conditions is significant with high rates of early mortality. The company anticipates making Epidiolex available within the next 6 weeks. Availability is primarily dependent on the time involved in obtaining the required Schedule V licenses for the US distributor and importer.
Medicines in Schedule V have a proven medical use and low potential for abuse. DEA’s decision to move Epidiolex to Schedule V was based on non-clinical and clinical data that evaluated the medicine’s potential for abuse and applies only to CBD products approved by the FDA. Other, non-FDA-approved CBD preparations remain in Schedule I.
Some examples of Schedule V drugs are cough preparations such as Robitussin and a number of commonly prescribed anti-epilepsy drugs such as Vimpat (lacosamide), Briviact (brivaracetam) and Lyrica (pregabalin).
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 will be marketed in the US by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals.