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Epidiolex Cleared for Clinial Trials in Japan

May 05, 2019

Although cannabis has been illegal in Japan since 1948 – with very harsh penalties mind you – the country has approved the CBD-based medication Epidiolex for clinical trials.

Despite the country’s uncompromising history with cannabis, strictly monitored clinical trials are exempt from the Cannabis Control Act. Japan has officially gave the green light for researchers to begin studying the effects of Epidiolex for epileptic patients with Dravet and Lennox-Gastaut syndromes.

Epidiolex was approved the by U.S. Food and Drug Administration (FDA) last June. It utilizes cannabidiol, which has been proven effective in treating seizures, and it’s the first cannabis-based medication to gain federal approval for the treatment of patients aged 2 years or older.

“It’s exciting to be able to offer another alternative for children with this debilitating form of epilepsy and their families,” said Dr. Ian Miller, from Nicklaus Children’s Hospital in Miami. The medication – an oral solution – was developed by GW Pharmaceuticals and it’s currently listed for $32,000 annually in the U.S.

Multiple studies have shown that Epidiolex can have life changing effects on people suffering from these conditions. Two separate phase 3 clinical trials ((NCT02091375 and NCT02224703) examining 189 Dravet patients showed that Epidiolex could reduce convulsive seizures by 38-44 percent and seizures in general (both convulsive and non-convulsive, by 39-51 percent.

In Japan, the trials were announced by the Ministry of Health, Labor and Welfare during a research and development meeting in Okinawa. According to an article in Hemp Today, there are around 3,000 Japanese residents living with Dravet syndrome and 4,300 with Lennox-Gastaut.

They have not yet announced a date for these trials to begin, so keep an eye out for an updated article from us with the exact dates and any new information.

For more information, make sure to subscribe to our Medical Cannabis Weekly Newsletter, the top source for all things cannabis-related.

The post Epidiolex Cleared for Clinial Trials in Japan appeared first on Cannadelics.





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