The Food and Drug Administration recently approved the first drug made from Cannabis sativa. This plant is known more often as marijuana. FDA approval of cannabidiol under the brand name Epidiolex is for treating two nearly intractable types of epilepsy in children. One is called Dravet syndrome, while the other is termed Lennox Gastaut syndrome. These specific syndromes are rare. However, GW Pharmaceuticals, the manufacturer, may be hoping that eventually its purified cannabidiol extract will prove useful against other maladies.
Approval of Cannabidiol as Medicine:
The company conducted three randomized placebo-controlled trials. In them, children with one of these hard-to-treat syndromes took either Epidiolex or placebo. All the youngsters in the studies also took another anticonvulsant drug. The drug does have side effects. Youngsters taking Epidiolex often felt drowsy, acted lethargic, had little appetite and experienced digestive problems such as diarrhea. Some had elevated liver enzymes, rash, infections and trouble sleeping. Still, such side effects pale in comparison to the benefit of controlling hard-to-manage seizures.
While medical marijuana is legal in a number of states, Epidiolex will at some point be legal everywhere in the country. Despite FDA approval, Epidiolex is still classified as a drug of abuse without medical merit. Before doctors can prescribe it as an ordinary anticonvulsant rather than a research compound, the FDA will need to change its classification. Because of the link to cannabis, this may prove politically sensitive.
Epidiolex is a far cry from marijuana, however. It may be derived from a natural product, but it has pharmaceutical-grade quality control behind it. Most natural product purveyors don’t have that capacity, so their cannabidiol (CBD) oil is likely to vary somewhat from one batch to the next.
The principal fear with marijuana is that people might abuse it in their enthusiasm for getting high. Epidiolex is not susceptible to that type of abuse, since it contains no compounds such as tetrahydrocannabinol (THC) that can produce a high. That is true in theory for other forms of CBD as well. Nonetheless, it is not clear that all are purified adequately to remove any traces of THC.
Uncertainties about Cannabidiol:
One big question about the approval of cannabidiol in the form of Epidiolex is whether and to what extent insurance will cover the cost. Much of the research was done at the drug company’s expense, but now that FDA has approved it, people who take it will have to find a way to cover the cost. While doctors can prescribe it off label for other types of epilepsy, insurance companies are under no obligation to cover off-label uses of any medicine.
Here is a link to a story we wrote before the approval of cannabidiol. It will be interesting to see how this story unfolds in the coming months.