The U.S. Federal Drug Administration has given unprecedented approval for two separate trials of Epidiolex, a liquid medicine made entirely of cannabis; the substance contains 98% cannabidiol, a nonpsychoactive compound found in cannabis – the remaining 2% consist of various trace amounts of other cannabinoids.
The studies will be led by Orrin Devinsky, MD at New York University’s School of Medicine, and Roberta Cilio, MD, PhD, at the University of California.
Each study will involve 25 participants, all children.
Epidiolex is manufactured by GW Pharmaceuticals, the company behind Sativex, a cannabis-derived medicinal spray which has been approved for treating multiple sclerosis in multiple countries, including Canada.
According to Geoffrey Guy, MD, chairman of GW Pharmaceuticals, cannabidiol is more than just an anti-seizure agent. “It’s anti-inflammatory, neuro-modulatory, and has been shown in animals to counter neonatal hypoxic ischemia [oxygen starvation during delivery]—an important problem you see after seizures in these children.”