The use of cannabis to treat epilepsy and other neurological conditions has been studied for a number of years. It has been hotly debated too.
On June 25, 2018, the U.S. Food & Drug Administration (FDA) approved EPIDIOLEXÂ® (cannabidiol, CBD) oral solution for the treatment of seizures associated with two epilepsy syndromes – Lennox-Gastaut syndrome and Dravet syndrome – in people two years of age or older. Epidiolex represents a new medication option for children with these types of epilepsy. It is also the first ever FDA approved medication to treat seizures in Dravet syndrome.
The FDA approval and Drug Enforcement Administration (DEA) scheduling of Epidiolex brings to market the first plant-based drug derived from the cannabis plant in the U.S.
Cannabis is known by many names – the most common is marijuana. Cannabis is the Latin name used most often by botanists and pharmaceutical companies. The word marijuana usually refers to the leaves and female flowers of the cannabis plant. Medical cannabis is whole plant marijuana or chemicals in the plant used for medical purposes.
Cannabinoids are substances in cannabis that act on cells in the body (called cannabinoid receptors) to cause some effect. Two major ingredients include
Early evidence from laboratory studies, anecdotal reports, and small clinical studies over a number of years suggest that cannabidiol (CBD) could potentially help control seizures. Research on CBD has been hard to do and taken time due to federal regulations and limited access to cannabidiol. There are also many financial and time constraints. In recent years, a number of studies have shown the benefit of specific plant-based CBD product in treating specific groups of people with epilepsy who have not responded to traditional therapies.
Hemp is a variety of Cannabis Sativa L. plant historically grown for fibrous materials found in its stalks and seeds. It has been used to make items such as clothing fiber, upholstery, and other household items.
Hemp traditionally contains lower concentrations of THC and higher levels of CBD. Cannabinoids extracted from hemp plants, including CBD, have until recently been classified as marijuana and considered Schedule I substances. Per the DEA, Schedule I substances currently have no accepted medical use and have a high potential for abuse. A federal law* enacted in December 2018, however, reclassifies hemp and hemp-derived CBD as an agricultural commodity and exempts it from the list of Schedule I Drugs.
Despite this change in the classification of hemp and hemp-derived CBD, the only CBD product that has been rigorously studied and approved to be used as a medical therapy for epilepsy is the drug Epidiolex. While more CBD products may come to market in the coming months, it is important to understand that not every CBD product is the same quality or uniform from batch to batch. Any drug or supplement that is being considered for use as a medical treatment should first be discussed with your doctor. The potential for benefit as well as the interaction with other seizure medications and possible side effects require careful review with your doctor.
*The Agriculture and Nutrition Act of 2018 (H.R. 2) legalizes hemp and hemp-derived CBD. The bill changes the definition of hemp to encompass any plant or product derived from the plant that contain less than 0.3% THC by dry weight and classifies them as exempt from the controlled substance restrictions applied to marijuana. The law further amends the Controlled Substances Act to exempt hemp from Schedule I drugs.
Studies in the U.S. of Epidiolex (a plant-based CBD formulation) have been ongoing for a number of years. Data from these studies has helped provide evidence that led to the FDA approval of this product on June 25, 2018.
Epidiolex is a purified (> 98% oil-based) CBD extract from the cannabis plant. It is produced by Greenwich Biosciences (the U.S. based company of GW Pharmaceuticals) to give known and consistent amounts in each dose.
Researchers studied this medicine in controlled clinical trials. These studies used a control group with some people taking a placebo while others were given CBD at different doses. Researchers did not know who was getting the placebo and who was getting CBD. These tpyes of studies are called â€śgold standardâ€ť studies.
A summary of the Epidiolex clinical trials is found below:
NEJM May 2018
Summarized below are the results from a study published in the New England Journal of Medicine in May 2018.
This study showed that the addition of CBD to a traditional seizure medication decreased the frequency of drop seizures significantly in children and adults with LGS.
NEJM May 2017
Summarized below are results from the May 2017 New England Journal of Medicine study examining the effectiveness of Epidiolex (CBD) in people with drug resistant seizures with Dravet syndrome.
This study was able to show that among people with the Dravet syndrome, CBD resulted in a greater decrease in convulsive-seizures than placebo. It also showed that CBD was associated with higher rates of adverse events.
Results from 214 people who received Epidiolex (99% CBD) in an open-label study (without a placebo control) and who completed 12 weeks or more on the drug were published in 2015 in Lancet Neurology.
An Israeli study using a product that had 20 parts of CBD to 1 part of THC was performed in an open-label format for children up to age 18 years with hard to control epilepsy. A significant number of people reported seizure reduction with 7% stating seizures worsened.
Marijuana or cannabis in general has a number of side effects depending on how it is used. For example, if smoked, the negative effect of smoking on a personâ€™s lungs and heart also apply to marijuana.
It is important to know that even though marijuana is a plant, it is broken down in a personâ€™s liver like many medicines. People mistakenly believe that marijuana is completely safe because it is a plant or oil from a plant. However, medication interactions can occur.
The safety data from the trials in people with Lennox-Gastaut syndrome and Dravet syndrome has shown similar side effects. Tiredness, diarrhea, and upset stomach are reported the most. Interestingly, people getting the placebo also reported diarrhea and upset stomach feeling as well. This may be due to both products being oil.
There are some drug-to-drug interactions that have been revealed during the studies of CBD in epilepsy syndromes. More research continues to be done examining these interactions. We know from studies that have been done:
The 2018 Farm Bill, signed into law by President Trump in December 2018, exempts hemp and hemp-derived products, including CBD, from the Controlled Substances Act. Previously, hemp-derivatives were classified as Schedule I cannabis products, meaning they had no acceptable medical use and had a high potential for abuse. The Farm Bill lifts federal restrictions surrounding CBD and legalizes the cultivation, manufacturing, and sale of these products across the United States. However, this does not mean that all hemp-derived products, including CBD, are medically appropriate.
Over half of U.S. states have laws allowing cannabis to be recommended and dispensed to people for medical reasons. The 2018 Farm Bill does not change existing laws surrounding state medical cannabis programs. Individuals who purchase treatments through a medical dispensary and via a recommendation from their physician are still required to follow the regulations set forth including registration, renewal of medical cards, and other requirements decided by each state.
In June 2018, the FDA approved Epidiolex allowing medical providers to prescribe this medication for Lennox-Gastaut and Dravet syndromes, similar to how they are able to prescribe other seizure medications. In late September 2018, the DEA rescheduled Epidiolex to Schedule V and all states and the District of Columbia have created pathways so that it can be brought to market for consumers.Read an FAQ to learn more.
Providers do not need a special license or certificate to prescribe Epidiolex. Epidiolex is the first and only plant-based treatment derived from cannabis for use as a treatment for seizures with FDA approval. Other formulations of medical cannabis have not been approved by the FDA.
When conventional treatments do not work to control seizures, as is the case for roughly 30% of people with epilepsy, it is not unreasonable to consider CBD oil. However, this should only be considered after a thorough evaluation at a specialized epilepsy center to look at whether all possible treatments (including FDA-approved new and add-on medicines, dietary therapy, devices, and surgery) have been reasonably tried.
The Epilepsy Foundation urges anyone exploring any treatment for their epilepsy, as permitted under their state law, to work with their treating physician to make the best decisions for their own care.
Learn about the Epilepsy Foundation’s state and federal advocacy efforts on removing barriers to cannabis research and supporting access to medical cannabis (marijuana) in consultation with the treating physician.