Cannabidiol, CBD, is a cannabinoid similar to delta-9-tetrahydrocannabinol, THC. CBD is used in oil form. CBD is believed to have therapeutic properties. Anecdotal reports of some children suffering seizures chronicle relief after using CBD.
Unlike THC, CBD has no psychoactive properties; you don’t get high from it. CBD is often bred out of the THC strain of marijuana because the CBD doesn’t have psychoactive properties.
Large doses of CBD, “High CBD” are frequently required to achieve desired therapeutic results. Extracting CBD from plant material is difficult to do, and the CBD extract can still contain differing levels of THC. The THC level can be high and consequently unsafe for children; kids can get high. Charlotte’s Web is a marijuana strain with “High CBD” and low levels of THC. CBD products lack standardization.
Drug development and manufacturing is problematic when the drug is derived from a botanical source. Botanicals can contain leaves, roots, stems, seeds, pollen, resin etc., and the parts can come from different plants.
CBD has not been approved by the Food and Drug Administration.
However, CBD is being tested in Dravet’s syndrome, a specific form of intractable seizures in kids. This is not for all kinds of seizures. The FDA is allowing phase III (in humans with the condition) trials under a special approval due to the unmet medical need of these kids. GW Pharmaceuticals has standardized CBD in the form of Epidiolex®. The FDA has approved the importation of the formulation of this drug and the sites where the study will take place.
Dr. Elson So, president of the American Epilepsy Society, writes, “ The recent discussions surrounding medical marijuana highlight the fact that the epilepsy community desperately needs new therapies and approaches for patients with resistant or refractory seizures. We need to know more about the basic mechanisms and causes of epilepsy so that we can better match therapies to patients, and someday soon find targets for cures.
But none of these giant steps forward will be possible without robust, careful research that safeguards the health of study participants while uncovering important new findings. 1
The U.S. Food and Drug Administration Approves A CBD Oral Purified Drug Substance Derived from Marijuana – Epidiolex
CBD is a chemical component of marijuana that does not cause intoxication or a “high.” GW Pharmaceuticals successfully developed a drug for patients with rare and severe cases of Dravet and Lennox-Gastaut epilepsy.2
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”3
1 Dr. Elson So, Epilepsy experts call for more research into medical marijuana, Miami Herald, January 22, 2014.
2 FDA Press Release, June 25, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm