The European Medicines Agency issues a positive opinion on Epidiolex

A panel of’European Medicines Agency (EMA) issued a positive opinion on Friday for Epidiolex, a CBD oil used to treat severe cases of epilepsy. Committee for Medicinal Products for Human Use (CHMP) of the EMA has given its approval, based on the results of four randomized controlled trials, for the potential marketing of cannabidiol oral solution to treat convulsions associated with Lennox-Gastaut syndrome or Dravet syndrome, in patients aged two years and over.

Although final approvals are the responsibility of the European Commission, they generally follow the CHMP's recommendations, approving them after a few months. So we'll have to wait for Epidiolex, produced by British GW Pharmaceuticals, is available on the European market.

Epidiolex is composed of cannabidiol (CBD), one of the hundreds of molecules present in cannabis, and contains less than 0.1% of tetrahydrocannabinol (THC), the plant's main psychoactive component. The drug's effects have been endorsed by clinical studies, including a research published in the New England Journal of Medicine, which suggests that two doses of Epidiolex can significantly reduce the number of epileptic seizures in people with Lennox-Gastaut syndrome. Another study on Cannabis dosage for children with epilepsy had also confirmed these results.

Last year, Epidiolex became the first cannabis-based medicine to be approved in the United States, after regulators approved the treatment of two other forms of epilepsy in children. It is already available in France under a personal Temporary Use Authorization (ATU).