First clinical study to prove the efficacy of cannabis on epilepsy

An experimental cannabis-based drug has successfully treated children with a very rare form of epilepsy during a long-awaited clinical trial.

The study investigated the effects of Epidiolex, a GW Pharmaceuticals drug, on Dravet syndrome, in the first stage of a group of 4 Phase III studies (the last before marketing) aimed at confirming the therapeutic benefits of GW products. cannabinoids, the active components of cannabis.

GW announced that trials on 120 patients showed that those treated with Epidiolex achieved an average reduction of 39% in their seizures, compared with 13% for placebo patients, which was statistically highly significant.

In light of these results, Executive Director Justin Gover announced that the company would request a meeting with the Food and Drug Administration (FDA), the U.S. agency responsible for food and drug safety, to discuss legal ways of approving the marketing of this drug.

To date, the FDA has not approved any therapy for Dravet syndrome, and is very reluctant to recognize the medical virtues of cannabis.

GW Pharma was created in 1998 with the aim of capitalizing on the therapeutic benefits of cannabis, by purifying the plant's active elements to avoid psychoactive effects.

Its treatment for multiple sclerosis, Sativex, is distributed in 20 countries, but not in the United States. In France, Sativex has been authorized but is still not available to patients due to a disagreement over its sale price.

Epidiolex, if approved, will be significantly more important for GW Pharma, as it holds full control of the product and has guided the drug's development for the US market. The Phase III testing program could be summed up as: it's a case of «make or break».

GW Pharma shares have risen by 123% since this morning at the time of writing.