(NJ) A nationally renowned pediatric neurologist at Saint Barnabas has gotten FDA approval to study whether a cannabis-based drug could prevent seizures in children diagnosed with severe forms of epilepsy.
The development is sure to be watched closely in New Jersey, where a number of families whose children have Dravet syndrome, a potentially deadly form of epilepsy, say they cannot obtain yet a useful form of medicinal marijuana through the state Department of Health.
The U.S. Food and Drug Administration gave Orrin Devinsky, director of the New York University and Saint Barnabas Comprehensive Epilepsy Center, Roberta Cilio of the University of California - San Francisco’s Neurology Department, and GW Pharmaceuticals of the United Kingdom permission to use the experimental drug, Epidiolex, to treat 125 children with seizure disorders for whom traditional medicines have failed.
Enrollment in the trial will begin next month, Devinsky said.
"I think this is a big step forward in the science of Cannabidiods," said Devinsky, referring to the spectrum of active ingredients in marijuana. "We will finally get some some data on epilepsy, and this should provide the basis to plan a randomized double-blind study.”