British drug company GW Pharmaceuticals will supply the medicine -- made entirely from cannabis plants grown at their fully licensed production facility in England -- to physician-researchers at the NYU School of Medicine and the University of California San Francisco. GW also produces Sativex, the world's first plant-derived cannabinoid prescription drug, currently available in 11 countries for the treatment of spasticity due to multiple sclerosis.
Ever since Dr. Sanjay Gupta used his CNN special "Weed" to show how CBD cannabis medicine helped a six-year-old child with Dravet's Syndrome reduce her seizures from 300 per week to just a few per month, doctors, patients and their families have been clamoring for access. Under these new IND studies, 50 children will initially ingest Epidiolex, a trademarked viscous CBD liquid that comes in a bottle with a syringe dropper, and the number of patients enrolled could increase quickly if the treatment shows promise.
“In the coming months, if the FDA is comfortable about how things are going, there will be a number of senior epileptologists in major university centers throughout the US, each treating a couple of dozen patients with various epilepsies,” said Dr. Geoffrey Guy, MD.
In 1978, as part of a lawsuit settlement, the US federal government begrudgingly began supplying whole-plant marijuana from a single approved facility in Mississippi direct to a handful of patients via the government's Investigational New Drug Program. When the FDA sought to significantly expand the program in 1992 by including HIV/AIDS patients, President Bush responded by killing it, though NIDA did agree to continue supplying already-approved patients. Today, only four of those patients remain grandfathered into the program.
So these new IND studies represent the first federally approved cannabis patients enrolled in the last 20 years, a major shift in government policy that reflects a growing consensus that the safety of medical cannabis can no longer be denied. The news should bring great hope to those suffering with pediatric epilepsy and many other serious conditions.