“New Cannabis Drug Approved For Trials In Children With Epilepsy
A new cannabis-based drug made by GW Pharmaceuticals has been approved by the U.S. Food and Drug Administration (FDA) for two separate trials involving children with epilepsy.
The drug is made from purified cannabidiol (CBD) – a non-psychoactive compound in marijuana – and is being marketed under the name Epidiolex, reports O’Shaughnessy’s.
So far, the FDA has approved two Investigational New Drug studies of Epidiolex for pediatric epilepsy, which are being led by Orrin Devinsky, MD, at the NYU School of Medicine, and Roberta Cilio, MD, PhD, at the University of California, San Francisco (UCSF). Each will involve 25 children with epilepsy, and other studies are awaiting approval.
If all goes as planned, GW Pharmaceuticals’ Chairman Geoffrey Guy, MD, expects more studies to begin within months.
“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 U.S., each treating a couple of dozen patients with various epilepsies.”
GW Pharmaceuticals is best known for its cannabis-based spray called Sativex, which is approved in over 20 countries for the treatment of multiple sclerosis symptoms.
However, the company has spent recent years developing a drug for epilepsy. Preclinical studies sponsored by the company show that CBD, along with a related cannabinoid called CBDV, have the potential to reduce epileptic seizures. Anecdotal reports also suggest that CBD-rich cannabis extracts could be effective in treating epilepsy in children.
Unlike Sativex, Epidiolex is a liquid medicine that can be administered with a syringe dropper. According to the company, the drug contains more than 98 percent CBD, along with trace amounts of other cannabinoids.”
More: http://www.leafscience.com/2013/10/22/new-cannabis-drug-approved-trials-children-epilepsy/