Jazz Pharmaceuticals, a British company, announced on Thursday that the phase III study for a cannabis-based epilepsy medication has begun in Japan.
The trial comes in response to a panel from the health ministry’s suggestion made in September that Japan’s drug laws be changed to permit the importation and use of medical cannabis products.
In a late-stage trial that will examine the safety and effectiveness of the medicine Epidiolex, Jazz’s GW Pharma reported that it has given the first dose to a patient. The trial is planned to include 84 participants.
Epidiolex is used to treat seizures linked to severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome and has received approval for usage in both the United States and the United Kingdom.
Allowing the import and use of medical cannabis products is advised by a Japanese health council.
A panel from the Japanese health ministry on Thursday suggested changing the country’s drug regulations to permit the importation and use of medical cannabis products.
According to the committee’s report, the proposal was made in order to address medical demands and bring Japan into compliance with worldwide standards. Products made from marijuana whose efficacy and safety have been established by regulations controlling medicines and medical devices would be subject to the amendment.
The importation, production, and consumption of illegal substances are all prohibited by Japan’s rigorous legal framework. In contrast to 20–40% in Western nations, only 1.4% of adults in Japan had ever smoked marijuana, according to the committee’s study.
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.
