Cannabis-derived Epidiolex Cleared for Clinical Trials in Japan for Dravet, Lennox-Gastaut Syndromes

Cannabis-derived Epidiolex Cleared for Clinical Trials in Japan for Dravet, Lennox-Gastaut Syndromes

In a departure from general government policy, Japan has approved the cannabis compound Epidiolex for clinical trials in epileptic patients with Dravet and 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.

Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
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Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
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