What Does FDA Approval Of Epidiolex Mean For The Future Of CBD?

The use of CBD in assisting various medical conditions has been gathering momentum. A recent development involving the FDA shifts things into high-gear. The US Food and Drug Administration recently approved CBD for use in treating two severe types of epilepsy.

Given the link between CBD and cannabis, support for patients wishing to use CBD for medicinal purposes is a hard-fought road. Often involving consultation with a physician, many will not condone its use, despite its non-psychoactive action—a direct result of the lack of understanding and stigma attached to cannabis overall. In extreme cases, CBD is even prohibited altogether in certain countries.

This latest development is the first of its kind; a significant milestone, not only for those living with epilepsy who will benefit from the medicine, but also for the future of CBD in general. The door has been swung wide open, ushering in a more progressive approach surrounding how CBD can help in the treatment of numerous conditions.

HISTORY OF CBD AND EPILEPSY

The use of CBD for the treatment of epilepsy is not a new phenomenon. Several previous studies have been undertaken, reviewing not only how effective CBD could be, but also its interaction with other epilepsy medications. Given the strength and intensity of some pharmaceutical medications, gaining clear insight on how they mix with CBD is often tricky.

Every new study represents another victory for CBD, all leading to the recent approval by the FDA. With the latest proposals authorising the use of CBD for treating Dravet syndrome and Lennox-Gastaut syndrome, previous clinical trials have proven vital in supporting this landmark decision. To that end, the summarised results of the earlier trials make for exciting reading.

WHAT DO THE TRIALS SHOW?

Each trial involved a double-blind methodology, using a placebo alongside prescribed epilepsy medication in one group, and a liquid formulation of CBD alongside similar medication in another. A total of 516 patients were involved, all of whom suffered from at least one type of two forms of extreme epilepsy that develop at a young age: Dravet syndrome, a rare genetic dysfunction of the brain and Lennox-Gastaut syndrome, a form of epilepsy that causes multiple seizures of differing types. Both types of epilepsy cause sufferers to experience numerous seizures per day.

In both control groups, caregivers were asked to monitor the frequency and severity of seizures over a prescribed period of time. The aim was to establish whether the CBD group would experience a lower number of seizures versus the placebo group. Neither the authors behind the studies nor the patients knew which group they belonged to.

Results were substantial. The CBD groups saw a reduction in seizures by more than 40% in Dravet syndrome sufferers, and a similar reduction rate in drop seizures caused by Lennox-Gastaut syndrome. There was an increased number of patients exhibiting side effects in the CBD group, but these symptoms (diarrhoea, sleepiness, and lack of appetite) were all found to be manageable by patients. The clinical trials provided “Class 1 evidence that CBD improves seizure control in patients with specific epilepsy syndromes”.

FDA APPROVES EPIDIOLEX

The decision by the FDA to approve Epidiolex (CBD) is a landmark decision for two reasons. Firstly, it is the first purified drug substance approved that is derived from cannabis. Secondly, it is also the first FDA approved drug that can be used in the treatment of Dravet syndrome. Its approval is undoubtedly incredible news for the sufferers and their families of these two severe conditions. Given that both these conditions develop in early childhood, the FDA approval extends to any patients over the age of two.

The role of the FDA (US Food and Drug Administration) is to protect the health of the public by assuring the safety, effectiveness, and security of human drugs. They also monitor the safety of the nation's food supply, cosmetics, and dietary supplements. To support the decision to approve CBD’s use, nonclinical and clinical studies were undertaken into the abuse potential of CBD. Given that the FDA provides recommendations to the Drug Enforcement Agency (DEA), the DEA will now be required to make a scheduling decision. Cannabis, from which CBD is derived, is still treated as a schedule 1 drug under federal law. The decision by the DEA will be vitally important in the future research possibilities of CBD and cannabis in general.

STRUGGLES IN OTHER COUNTRIES

The battles experienced by people living with epilepsy across the globe is not over. Cannabis legislation is a complicated minefield, with each country or state within a nation adhering to different laws. Generally speaking, because cannabis is still primarily viewed as an illegal substance, research into specific cannabinoids like CBD, even if they are non-psychoactive, is often micromanaged or prohibited altogether.

Recent struggles in the UK saw Billy Caldwell, aged 12, denied medical cannabis—something he had been taking to manage his severe seizures. Because cannabis is classified as a class 1 drug in the United Kingdom, Billy's medical cannabis was confiscated, and he was hospitalised as a result of multiple seizures. Special exceptions were made for Billy, and after successfully receiving his medication, his seizures returned to a reduced frequency.

Billy is but one example of how cannabis and CBD have been used effectively to assist people living with epilepsy. The problem lies in understanding more about how CBD interacts with other medication and what other conditions it could be used to treat—something that will only happen as a result of more in-depth research.

WHAT DOES THE FUTURE HOLD FOR CBD?

Approval by the FDA displays a distinct shift in the way CBD is perceived. It also marks the start of a landslide of favourable anecdotal reports and (hopefully) increased research grants. It would be easy to tar cannabis and its cannabinoids with the same brush. While there may be concerns around the use of THC, CBD thus far does not appear to show any of these side effects. Clinical trials have also reviewed the risk of substance abuse through excessive CBD intake, deeming it not a threat.

With the FDA influencing the scheduling decision of the DEA, their input is momentous. It also signifies to the rest of the world’s health organisations that CBD is a substance to be taken on its own merit for medicinal use. The victory for sufferers of Dravet syndrome and Lennox-Gastaut syndrome will be life-changing. The future of CBD will unquestionably continue to provide victories as it becomes accepted on a larger scale and further research is conducted to offer comprehensive conclusions.