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The Food and Drug Administration of June 25 approved for the first time a drug based on Cannabidiol (CBD), a molecule derived from the cannabis plant. The drug, Epidiolex, has been approved for the treatment of two types of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, who have resisted treatment.
Well-designed clinical trials have shown that Epidiolex product of CBD can help reduce or eliminate seizures in these epileptic syndromes.
Advocates of medical marijuana may quote the FDA's approval of Epidiolex as evidence of the benefits of marijuana. it is not an endorsement of a CBD product or cannabis. This product differs from most other CBD products available in cannabis dispensaries in that it is a highly concentrated and purified pharmaceutical grade drug. This is the only CBD product to receive FDA approval, yet. Other pharmaceutical grade products can be developed and approved in the future. In addition, this product could be approved by the FDA for other types of epilepsy or diseases.
The next step in the process of making this CBD product available is rescheduling by the Drug Enforcement Agency. At present, CBD is an Schedule I drug, which means that it has potential for abuse and no proven medical use. As a Schedule I drug, the use of CBD is highly restricted and controlled. Now that the FDA has approved a medical use, the DEA has 90 days to postpone the drug, making it available for medical uses.
It is not known for the moment what the DEA will determine as an appropriate timetable for the CBD. Once the DEA has postponed the CBD, the Epidiolex product will be available for the doctors to prescribe. While the FDA's current approval of this CBD product is for two specific epilepsy syndromes, the FDA does not limit its use solely to epilepsy. Doctors will be able to legally prescribe this product for any use when they believe that there is sufficient scientific evidence.
As a pharmacy professor with a particular interest in epilepsy, I find it important that CBD be a new option for treatment. of epilepsy. This new use has led me to carefully review the published literature on CBD and discuss it as an option with patients with epilepsy. In addition, I have participated in the ongoing CBD review by the American Epilepsy Society as a possible treatment for epilepsy. From this point of view, I believe that CBD can offer benefits to patients with certain types of epilepsy and possibly other disorders.
Not high, but healing
The cannabis plant produces hundreds of different compounds. have different effects in the body. Tetrahydrocannabinol, or THC, is the substance best known for its psychoactive effects, or the "high" badociated with marijuana.
However, there are many other substances in the cannabis plant that also produce effects in the body. Many of them differ from THC in that they are not psychoactive – and they do not produce "high". Cannabidiol, or CBD, is one of these substances.
Cannabidiol is a complex molecule produced by the cannabis plant. Cannabis has been proposed for centuries as a medicinal plant. It is only recently that CBD has been scientifically studied for various disorders.
Compared with THC, CBD acts on different receptors in the brain and other parts of the body. In this way, CBD is very different from THC and can offer new treatment mechanisms. For this reason, the CBD has received a lot of attention as a possible treatment for many different disorders.
CBD has been proposed as a cure or treatment for many disorders and diseases, including epilepsy, chronic pain, anxiety, multiple sclerosis amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) ) and insomnia. Some of these uses are science-based, but others are proposed by advocates of CBD and medical marijuana. Several anecdotal reports, case reports, case series and small studies have reported on CBD for many of these disorders. The information from these reports is contradictory. Case reports, case series, and small studies are considered insufficient evidence to prove or disprove the safety and effectiveness of a drug or treatment. Indeed, these studies are usually unable to distinguish between the effect of a drug and a placebo effect, the patient thinking that the drug works when it is not really beneficial.
However, there are two large, well-designed studies. this indicates that CBD is effective in both different epilepsy syndromes. In these studies, approximately 40% of patients taking CBD had a significant reduction in some types of seizures.
Epilepsy is the only disorder where there is strong scientific evidence demonstrating that CBD is safe and effective. This does not mean that CBD will not work for other disorders, but epilepsy is the only one where we have clear and well documented evidence that CBD helps.
The results of these studies show that CBD has side effects. The most common are drowsiness, nausea, intestinal cramps, bloating and diarrhea. More serious side effects may occur. In one of the studies on epilepsy, about 10% of patients treated with CBD had an increase in laboratory tests of liver function. These tests usually indicate liver damage. About 2 to 3% of patients taking CBD had to discontinue it due to large increases in some liver enzymes in laboratory tests, showing possible liver damage.
We are also studying the drug interactions that occur with CBD. In these studies, CBD slowed the metabolism of several medications commonly administered to people with epilepsy. Interactions between CBD and other drugs took side effects. It is not known if these side effects were due to CBD, other drugs or a combination. The doses of the other drugs have been reduced because of the interactions.
The mechanism of these interactions indicates that there are probably several other interactions between CBD and other common drugs. Cannabidiol should be used with caution in combination with other drugs
Problems Beyond Efficiency
There are several other factors to consider regarding the CBD. Cannabidiol does not dissolve well in water. For this reason, CBD oral products are made with an oil, often a type of vegetable oil. It is important that the right oil is used.
In addition, less than 20 percent of an oral dose of CBD is absorbed. This makes it difficult to produce a CBD product where CBD is absorbed reliably and consistently.
An FDA study of unregulated CBD products available on the market shows that these products are frequently contaminated with products such as pesticides, herbicides, fungi or bacteria. In addition, the FDA has found that more than 50% of CBD products do not contain the amount of CBD on the label. This is especially true in states where CBD products are not regulated by the state. In 17 states where there is regulation, there is much more control over the quality and purity of the product.
Finally, two pharmaceutical grade CBD products were studied for production by a pharmaceutical company. One is Epidiolex, and the other is still under study.
Up to now, the proof is that CBD is safe and effective for specific epilepsy syndromes. The scientific evidence is insufficient to indicate whether it is effective or ineffective for other disorders. Information from well-designed studies indicates that CBD causes significant side effects and drug interactions that need to be taken into account. Those wishing to use CBD should be managed and monitored by health professionals familiar with its use.
Learn more:
Why marijuana fans should not see the approval of epilepsy as a victory for weeds
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