Epidiolex, a drug derived from the marijuana plant that’s been tested in research involving children with a severe form of epilepsy – including two dozen children in Idaho who are receiving the drug under a “compassionate use” program – is sharply reducing violent seizures suffered by the children, according to a study published in the New England Journal of Medicine. The drug, whose main ingredient also is known as cannabidiol, cut the median number of monthly convulsive seizures from 12.4 to 5.9 in 52 children with Dravet syndrome who took the medication over a 14-week test period; 56 children using a placebo saw the number of seizures drop only from a median of 14.9 to 14.1 per month.
Gov. Butch Otter vetoed legislation in 2015 that would have allowed Idaho parents of children with intractable epilepsy to treat their children legally with cannabidiol, or CBD oil. Following the veto, he issued an executive order allowing up to 25 carefully screened Idaho children to receive Epidiolex under a compassionate use program. In February, the Idaho Department of Health and Welfare reported that the drug appeared to be helping Idaho kids, and requested expansion of the state program to up to 39 children, to accommodate all those on a waiting list; Otter and lawmakers approved the expansion, at a cost of $128,600 in state funds.
All Idaho kids in the program receive the real drug, not a placebo. But the Washington Post reports today that Epidiolex is not available anywhere in the world, except to about 1,500 children who are receiving it from the manufacturer, GW Pharmaceuticals, under compassionate-use rules for Dravet syndrome, a condition that causes ongoing seizures, cognitive problems and risk of early death.
GW Pharmaceuticals CEO Justin Glover told the Post the company plans to submit the drug for approval by the Food and Drug Administration in the middle of this year with the hope that it could be available by prescription in 2018 for children with Dravet and another severe form of epilepsy, Lennox-Gastaut syndrome. The company announced in March 2016 that an earlier stage of the study had shown the drug to be effective. “The important thing for us is that patients like this deserve a pharmaceutical solution,” Glover said; you can read the Post’s full report here. Glover said the firm conducted 18 years of basic research before beginning development of the drug three years ago.
Epidiolex is not psychoactive; it lacks the intoxicating component of marijuana.