Cannabis-derived Epidiolex Cleared for Clinical Trials in Japan for Dravet, Lennox-Gastaut Syndromes
Although the country prohibits cannabis-based agents overall, tightly monitored hospital trials are exempt from its Cannabis Control Act. Epidiolex is a plant-derived cannabidiol (CBD) which does not have the mind-altering effects characteristic of the marijuana component delta-9- tetrahydrocannabinol (THC).
The trials were announced recently by Japan’s Ministry of Health, Labor and Welfare officials during a meeting of the research and development agency Okinawa-Northern Task Force. According to an article in Hemp Today, which included news of the trials, about 3,000 residents have Dravet in Japan, and 4,300 live with Lennox-Gastaut.
It’s unclear when the trials will begin.
Epidiolex was approved last June by the U.S. Food and Drug Administration, making it the first cannabis-derived prescription therapy to gain federal approval in the United States for patients age 2 or older with two severe forms of epilepsy — Dravet and Lennox-Gastaut syndromes. The oral solution developed by GW Pharmaceuticals is listed for $32,500 annually in the U.S.
In addition, the European Medicines Agency is reviewing Epidiolex to treat Dravet and Lennox-Gastaut, and its decision is expected this year.
The agent is a purified form of CBD, the predominant non-psychoactive cannabinoid compound in the cannabis plant. CBD can mimic natural compounds that act on brain receptors which, when faulty, can produce seizures. Still, scientists do not fully understand how cannabidiol works to treat epilepsy.
Results from two Phase 3 clinical trials (NCT02091375 and NCT02224703) included 189 Dravet patients, and showed that treatment with Epidiolex could reduce convulsive seizures by 38–44%, and all seizures by 39–51%.
The treatment has also been shown to improve overall health and clinical status in about 80% of patients at six months and one year of treatment.
The Department of Justice and the U.S. Drug Enforcement Administration cleared the use of Epidiolex in October by placing it in schedule V of the Controlled Substances Act (CSA). Schedule V is the least restrictive classification of the CSA, meaning that the agent is considered to have low potential for abuse as it contains a low amount of a narcotic compound, in this case the cannabis plant-derived compound cannabidiol.