In early 2016, GW Pharmaceuticals published the results of the first phase of their study on a CBD-based medicine, which is being developed to treat two extremely drug-resistant forms of epilepsy. The study is actually the first cannabis-related study to be approved by the FDA and the results have been very positive. Now they have released the results for the third phase, which continue to show the efficacy of the drug as a treatment for patients with epilepsy.
“For many children with treatment-resistant Dravet syndrome, Lennox-Gastaut syndrome and other epilepsies, CBD appears to be an effective – sometimes extremely effective – treatment that is safe and well-tolerated overall,” said study author Elizabeth Thiele, M.D., Ph.D., director of the Pediatric Epilepsy Program at Massachusetts General Hospital, Boston, and professor of neurology at Harvard Medical School, in a prepared statement. “It’s not a silver bullet, but there are children who benefit from this more than they have from other treatments.”
The study is completely controlled and separately tracks patients with Dravet Syndrome and Lennox-Gastaut Syndrome. There is a total of 120 children with Dravet Syndrome in the study, 61 of them have been receiving the CBD medication Epidiolex twice a day for 14 weeks and the other 59 of them have been receiving a placebo – and so far the results have been an average 39% decline in number of seizures for those receiving CBD and only a 13% decline in the placebo group. Three of the patients in the Epidiolex group even stopped having seizures all together – and if that’s not impressive, I don’t know what is.
The results for the patients with Lennox-Gastaut Syndrome are just as promising – with a total of 171 children and adults between the ages of 2 and 55. Of that group, 86 patients received Epidiolex and 85 received the placebo, both twice a day for at least 14 weeks. By the end of the 14 weeks they saw a 44% reduction in “drop seizures” in patients taking the CBD medication compared to 22% in the placebo group. The results of both of these studies show that Epidiolex has a good chance at being one of the next epilepsy drugs available to patients around the world.
“It is all coming to fruition. In terms of timing, 2016 has all been about generating the data to support Epidiolex, next year is all about submitting and making it a reality.”
With the trial going so well, it is time for the company to start thinking about distributing this medicine on a much larger scale. If this medication is approved in the U.S. it would likely come with a long awaited rescheduling of cannabis – but the company is based in the U.K. and even though they will distribute Epidiolex on an international scale, they will continue to keep the production of the medicine local. Currently they only have the capability of producing about 40,000 doses of the medicine – but they do have intentions of expanding in the U.K. to prepare to produce it on a much larger scale.
There is a lot of excitement surrounding this medicine as it is the largest study relating to CBD that is approved by multiple governments – and it’s producing some amazing results so far. Hopefully, by this time next year, it will be approved as a treatment for these two rare forms of epilepsy.