CBD-based Medicine to be Submitted to FDA

After 18 years of research and three years in development, the CBD product known as Epidiolex will soon be sent to the Food and Drug Administration (FDA) for approval sometime this year.

Recently the New England Journal of Medicine released the full results of a 120-person study involving Epidiolex, which was subsidized by GW Pharmaceuticals and conducted by Orrin Devinsky, director of the Comprehensive Epilepsy Center at NYU Langone Medical Center, who operated the research initiative over a 14-week period. The study was conducted with children who suffer from Dravet syndrome, and provided some miraculous results that might help gain the attention of the FDA. “These results suggest that Epidiolex can provide clinically meaningful benefits and I look forward to the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol available as a treatment option for these patients,” said Devinsky.

Epidiolex, which contains CBD oil and less than 0.01 percent of THC was administered to their patients in ages ranging from 2 to 18 years, in syrup form. The results of the study showed that 43 percent of the children who took the medication saw their seizures cut in half, while five percent saw their seizures completely stop altogether. The CBD oil played a pivotal role in cutting the children’s monthly convulsive seizures from 12.4 to just 5.9, while those taking the placebo saw their numbers go from 14.9 to 14.1. These numbers are unprecedented and could improve the quality of life for many children who suffer from conditions such as Dravet syndrome.

Dravet syndrome, is a lifelong from of epilepsy that occurs within the first year of the child’s life and includes frequent and prolonged seizures which could have debilitating effects on their behavioral and developmental growth. There are currently very limited treatment options and those who suffer from Dravet syndrome have a 15-20 percent mortality rate due to SUDEP (Sudden Unexpected Death in Epilepsy.)

Because of FDA regulations, there is no way for patients to receive the medication except by getting it directly through GW Pharmaceuticals. Currently, there are 1,500 children receiving Epidiolex under the compassionate-use rule for the illness. If the FDA does pass Epidiolex, the goal is to make it available for prescription by 2018.