TOKYO - The Japanese unit of Britain's Jazz Pharmaceuticals PLC (JAZZ.O) said on Thursday it had started a phase III trial of a cannabis-based drug for epilepsy.
The trial follows a recommendation by a health ministry panel in September to revise Japan's drug laws to allow for the importation and use of medical marijuana products.
Jazz's GW Pharma said it had administered the first dose to a patient in a late-stage trial expected to involve 84 participants, testing the efficacy and safety of the drug, Epidiolex.
Epidiolex has been approved for use in Britain and the United States and is used to treat seizures associated with severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
Japan health panel recommends allowing import, use of medical marijuana products
A Japanese health ministry panel on Thursday recommended revising the nation's drug laws to allow for the importation and use of medicinal marijuana products.
The recommendation was based on meeting medical needs and to harmonise Japan with international standards, the committee said in a report. The revision would apply to marijuana products whose safety and efficacy were confirmed under laws governing pharmaceuticals and medical devices.
Japan has very strict laws banning the importation, production, and use of illicit substances. The committee's report noted that only 1.4% of people in Japan had ever used marijuana, compared to 20-40% in Western countries.
Revision of the law would be necessary for the use of the cannabis-derived epilepsy drug Epidiolex, which is currently undergoing clinical trials in Japan, the report said.
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