What does FDA approval of Epidiolex mean for the future of CBD?

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The use of CBD to combat various medical conditions has been gaining traction for some time. And a recent FDA-related breakthrough has sped up this process. The US Food and Drug Administration has approved the use of CBD for the treatment of two severe forms of epilepsy.

Given the relationship between CBD and cannabis, finding support for sufferers who want to use CBD for therapeutic purposes has always been difficult. It often involves a consultation with a doctor, and many of them do not approve of its use despite not being psychoactive, a direct consequence of the stigma and lack of knowledge surrounding cannabis in general. In extreme cases, CBD is even banned in certain countries.

This latest event is the first of its kind and an important milestone, not only for people with epilepsy, but also for the future of CBD in general. The door is now open to a more progressive approach to how CBD can contribute to the treatment of numerous diseases.


The use of CBD for the treatment of epilepsy is not a new phenomenon. Numerous studies have been carried out determining the effectiveness of this cannabinoid and its interaction with other epilepsy medications. Considering the potency and intensity of some of them, it’s hard to get a clear picture of how they might stack up with CBD.

Each new study represents another victory for CBD, and all of them have led to its recent approval by the FDA. Following the latest proposals, the use of CBD has been authorized for the treatment of Dravet and Lennox-Gastaut syndromes, so clinical trials have proven to be of vital importance for this historic decision. The summary of the test results is a very interesting report.


The double-blind method was used in all trials, with a placebo and a prescription drug in one group, and a liquid formulation of CBD and a similar drug in the other. They enrolled 516 patients, all of whom had at least one of two severe forms of epilepsy that developed at an early age: Dravet syndrome, a genetic dysfunction of the brain, and Lennox-Gastaut syndrome, a form of epilepsy that causes multiple attacks. Both forms of epilepsy cause sufferers to experience numerous seizures daily.

For both control groups, seizure frequency and severity were tracked over a certain period of time. The goal was to determine if the CBD group would experience fewer seizures than the placebo group. Neither those responsible for the study nor the patients knew to which group each patient belonged.

The results were very relevant. The CBD group experienced a more than 40% decrease in seizures among those with Dravet syndrome, and a similar reduction in the number of seizures caused by Lennox-Gastaut syndrome. There was an increased number of patients experiencing side effects in the CBD group, but these symptoms (diarrhea, drowsiness, and lack of appetite) were manageable. These clinical trials provided “conclusive evidence that CBD improves seizure control in patients with specific epilepsy syndromes.”


The FDA’s decision to approve Epidiolex (CBD) is a landmark resolution for two reasons. First of all, it is the first purified cannabis-derived drug to be approved. Second, it is the first FDA-approved drug that can be used for the treatment of Dravet syndrome. This approval is excellent news for sufferers of these two serious disorders and their families. Since both diseases develop in early childhood, the FDA approval applies to any patient older than two years.

The role of the FDA (United States Food and Drug Administration) is to protect public health by ensuring the safety, efficacy, and safety of the drugs consumed. It also oversees the safety of the national supply of food, cosmetics, and dietary supplements. In making the decision to approve the use of CBD, numerous clinical and non-clinical studies have been carried out on the potential for abuse of this cannabinoid. Since the FDA is the agency that provides recommendations to the Drug Enforcement Administration (DEA), the DEA will now have to make a decision regarding the classification of this substance. Cannabis, from which CBD is derived, remains a schedule I substance under federal law. The DEA’s decision will be vitally important for the future of CBD and cannabis research in general.


The struggle of patients living with epilepsy is not over yet. Cannabis legislation is a minefield, as each country, or state within the same nation, has different laws. In general, and since cannabis is still considered primarily an illegal substance, research into cannabinoids like CBD (despite not being psychoactive) is often highly controlled or prohibited altogether.

The UK government recently banned 12-year-old Billy Caldwell from using medical marijuana, which he needed to control his severe seizures. Cannabis is classified as a class 1 substance in the UK, so Billy’s medicine was confiscated and the little boy ended up hospitalized as a result of several attacks. A special exception was made in his case, and after receiving his medication, Billy’s seizures became less frequent again.

Billy is just one example of how cannabis and CBD are used effectively to help people with epilepsy. The problem lies in understanding how CBD interacts with other medications, and for what other conditions it might be beneficial, something that will only happen as a result of more extensive research.


This FDA approval demonstrates a change in the way CBD is perceived. It also marks the start of a deluge of favorable anecdotal reports and (hopefully) increased funding for your research. It would be very easy to put cannabis and cannabinoids in the same bag. While there is a lot of concern surrounding THC use, CBD does not appear to cause any of its side effects. Clinical trials have also examined the risk of abuse of CBD, and have concluded that it does not pose a threat.

Given the FDA’s influence on DEA decision-making, their input is critical. For health agencies in the rest of the world, it also means that CBD is a substance that can be consumed for medicinal purposes. This victory will change the lives of those suffering from Dravet and Lennox-Gastaut syndromes. The future of CBD will continue to provide success as it is increasingly accepted and more research is carried out in order to offer comprehensive conclusions.

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