A new marijuana-based drug was shown to reduce epileptic seizures in its first clinical trial. The findings were recently reported on by The New York Times.
The trial involved 120 Dravet syndrome patients who on average experienced 10 to 13 seizures a month at the beginning of the study. Half of the children were given the new drug, Epidiolex, and the other half were administered a placebo to be taken along with the other epilepsy medicines they were already taking.
The seizure rate for patients taking Epidiolex fell 39 percent over the 14-week treatment period. For patients given the placebo, rates fell by 13 percent.
"I'm very proud and happy about this study because it is science — we did things the way they should be done," the study's lead investigator, Orrin Devinsky, MD, director of the Comprehensive Epilepsy Center at New York University Langone Medical Center, told the Times. "I would strongly advocate that in the United States we need to do systematic assessments of medical marijuana."
According to the Times, hundreds of children and young adults have already been taking Epidiolex under programs that allow desperate patients access to experimental drugs. Parents of these patients have reported substantial reductions in seizures, but experts remained cautious asserting that the treatment needed to be compared with a placebo to prove efficacy.
GW Pharmaceuticals, the London-based developer of the medication, will meet with the Food and Drug Administration to see if regulatory approval could be achieved from the merits this single study. If it is approved, it will be the first prescription drug in the U.S. extracted from marijuana.
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