All medicines, no matter how catchy their scientific names, need to have a brand label in order to be recognizable and marketable. This might sound a little odd, but it’s a necessity in the very “brand-aware” culture of the medical world.
For cannabis, the only branding that could be ascribed to the drug is through recreational varieties created in legal states (i.e. strain names); we’ve yet to have any kind of legal form of the herb approved by the Food and Drug Administration to assign it federal approval.
Until, that is, Epidiolex hit the market.
What is Epidiolex?
Epidiolex is the newly approved brand name of the prescription drug form of cannabidiol, otherwise known as CBD. This has been something that people have been fighting for decades for; official approval by the federal government of a natural cannabis-based medicine.
This might not seem significant to those that live in states where medicinal cannabis (or better yet recreational cannabis) is currently legal. If you need cannabis for a medical condition, you can just go and buy it, possibly with a medical prescription from a doctor.
However, there is still a huge number of US states that do not have any form of cannabis legality – if you buy it and get caught, there’s a likelihood that you’re going to jail. Sounds crazy in today’s day and age, but it’s true.
To fight this, you need the federal government to fully and completely recognize a drug and give it their seal of approval. As of this year, this has finally happened, and this particular drug’s name is Epidiolex.
Why Does FDA Approval of Epidiolex Matter?
The seal of approval from the Food and Drug Administration might seem like a piece of unnecessary red tape to some, but FDA approval is basically the biggest hurdle for any type of new substance to succeed in the nation’s marketplace. Without their say so, you’re not getting anywhere.
It’s hard enough for makers of actual food and drink to get FDA approval, with some producers reporting that it can take years for the FDA to get around to actually testing and approving their product.
We have long since known about the medicinal value of cannabis and its uses in treating in a variety of diseases and conditions, but it wasn’t until now that the FDA has finally, officially, and with very little fanfare, declared Epidiolex tested and approved.
Most importantly, this means that doctors can prescribe it across the USA, even in states with strict anti-cannabis laws and attitudes. This is such a huge milestone for cannabis as it represents not only federal approval of a cannabis product that isn’t a textile (like with regular hemp), but it also demonstrates the federal government’s willingness to consider alternatives to its extremely aggressive anti-drug laws and regulations.
The war on drugs has been fought for decades now, but with the legalization and recognition of Epidiolex, we are starting to see the first steps towards ending it. Epidiolex is now approved for medical use for only two specific conditions, both of which are severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. Additionally, the patient needs to be two-years-old or older to be able to get it.
As of September 2018, Epidiolex was added to Schedule V of the Controlled Substances Act, an exception built into the primary law that criminalizes drugs for the purpose of medicinal use. So, what are Lennox-Gastaut syndrome and Dravet syndrome, and how does Epidiolex actually help them?
Conditions that Epidiolex is Prescribed for
Lennox-Gastaut syndrome and Dravet syndrome are two forms of rare and dangerous epilepsy. Both diseases represent the worst of possibilities for suffers of childhood epilepsy, as they cause severe and often completely untreatable seizures.
In the case of Lennox-Gastaut syndrome, or LGS for short, it causes not only multiple and concurrent seizures, but also severe cognitive dysfunction and sudden, intense brain activity. This occurs early in childhood, but only gets worse as you age.
Though the mortality rate is only 5%, one study by Asadi-Pooya for the Neurological Society discovered that this syndrome still results in seizures in adulthood as much as 75% of the time.
With Dravet syndrome, the same overwhelming and disruptive seizures occur, only they can be triggered by fevers or even something as simple as hot temperatures.
This condition is so unpleasant because the seizures are triggered not necessarily from within the body, but based on external factors you might not be able to control. Some sufferers of the syndrome report seizures due to slight temperature fluctuations, or simply from their air conditioning turning off.
Perhaps the most famous case of Dravet syndrome is Charlotte Figi, who suffered upwards of 300 grand mal seizures per month and was experiencing significant developmental decline as a result of her condition. Her parents were at a loss of what to do, but were eventually convinced to try cannabidiol, also known as CBD, to try and treat it.
Thanks to the Stanley Brothers’ cannabis breeding expertise, they were able to create a strain with an extremely high concentration of CBD to try and treat her condition.
It was a rousing success, with her seizure frequency decreasing from 300 per month to only 3 or 4. The resultant cannabis strain was named Charlotte’s Web, and is still commonly used now to treat Dravet syndrome.
However, we now have a different option; Epidiolex. This is the reason that Epidiolex has been legalized to help treat these two specific conditions, as Epidiolex is essentially a pure CBD extract in medicinal form.
However, what exactly is cannabidiol, and why is CBD so good at treating these conditions?
What is Cannabidiol & What is it Used for?
Cannabidiol is one of the primary cannabinoids within the Cannabis sativa plant, and is similar in chemical composition to its more “fun” cousin, THC. However, unlike THC, CBD does not in any way give you a high.
When you consume CBD, it interacts with something called the endocannabinoid system (ECS), a health system that runs throughout the human body. This system is primarily composed of two major receptors, the CB1 and CB2 receptors. These are scattered throughout the body.
The CB1 receptor is primarily located within the brain and the central nervous system, whereas the CB2 receptor is more generally spread throughout the body, allowing it to have more widespread effects. Each receptor, when activated, triggers different effects for the body. For example, when the CB1 receptor is triggered, it encourages the release of helpful neurochemicals like serotonin and melatonin, as well as aiding in the preservation of neurological cells.
The CB2 receptors, meanwhile, are responsible for healthy cellular regeneration, as well as the body’s inflammatory response. Thanks to the way in which they interact with the ECS (namely, not clinging directly to the receptors like THC does, but instead triggering them passively and overtime), CBD doesn’t overcharge or over stimulate the ECS and does not result in a high.
Additionally, CBD is a natural antioxidant, as discovered in a few seminal studies, such as the one published in the National Academy of Sciences of the USA by Hampson et al., which is something very useful in helping fight against oxidation of brain cells, one of the leading causes of various degenerative disorders.
This last feature, as well as the CB1 receptor’s ability to help repair and defend neurological cells, is the primary reason that CBD is prescribed for both Dravet syndrome and for Lennox-Gastaut syndrome. With the full federal recognition and legalization of Epidiolex, however, patients with either syndrome can now access a safe, easy and fully legal version of CBD to treat themselves with.
But as a patient, how do you actually get your hands on Epidiolex?
How Do You Get Epidiolex?
It’s all well and good to know about Epidiolex and be aware of its usefulness for two major forms of epilepsy, but how do you actually get your hands on it? Well, an unfortunate part of being recognized by the FDA as part of their medical program is that Epidiolex is now a fully prescription drug.
This means you need to have it prescribed to you or your child by your general practitioner. While it is entirely legal across all 50 states (and Puerto Rico), some doctors might still be hesitant to recommend it, as it is up to your doctor to recommend medication.
If you suffer from either Dravet or Lennox-Gastaut syndrome and you want to try it, consider suggesting it to your doctor and asking to be prescribed this drug. If they refuse for whatever reason, there’s nothing stopping you from getting a second opinion.
There is a small possibility of getting Epidiolex if you don’t suffer from these two forms of epilepsy, however. Due to the way in which the research cases for Epidiolex were so popular, the FDA began allowing roughly fifty different hospitals that weren’t part of the original trial to also prescribe Epidiolex.
This allowed a lot more doctors to use the drugs for their patients without the strict approval of the FDA, as they can do something called “prescribing off-label”. This simply means that the doctor thinks it’s a good idea to recommend this drug, even though it hasn’t necessarily been officially proven to work with a particular condition.
Considering the wide range of conditions with which CBD has been demonstrated to help treat, consider asking your doctor and seeing if he or she can “bend the rules” just a little bit and try to get you a prescription. It’s medicinal, it’s helpful and, perhaps best of all, it’s completely legal.
Who knows what’s next in the fight for cannabis legalization? No matter what it is, Epidiolex is the first major step of many towards full federal acceptance.
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