Japanese officials approve Epidiolex for clinical trials

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Japanese officials have a approved the medical CBD brand Epidiolex for clinical trials, marking the first time such products have been approved by the Japanese government.

The trials, to be tightly controlled in a hospital environment, are exempted from Japan’s Cannabis Control Act, which bans cannabis compounds generally.

Epidiolex, manufactured by UK-based GW Pharmaceutical, was approved by the U.S. Food and Drug Administration last year.

Ministry of Health, Labor and Welfare officials recently announced the trials during a meeting of the Okinawa-Northern Task Force, a research and development agency.

Epidiolex was crafted as a treatment for two forms of childhood epilepsy. It is the first cannabis-derived prescription drug to gain federal approval in the United States.

It was primarily developed for the treatment of two severe forms of epilepsy — Dravet Syndrome and Lennox-Gastaut Syndrome. In Japan, there are approximately 3,000 patients who suffer from Dravet Syndrome, and some 4,300 afflicted with Lennox-Gastaut.


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