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Epidiolex is Schedule V: Why?

Over the past few years, the Food and Drug Administration (FDA) has been reviewing and approving a few different cannabidiol (CBD) based medications. This includes one called Epidiolex. This approval has also led to Epidiolex receiving a Schedule V designation by the FDA. But what does that mean? And what even is Epidiolex? Or CBD? Because we here at Panacea Life Sciences are dedicated to educating people on CBD, we thought we should cover all of this.

What is CBD? What is Epidiolex?  

It is essential to understand any medication that you or a loved one may take. So, let’s define medication and the main active ingredient in it, CBD.  

CBD is found in cannabis plants, like hemp and marijuana. It is a member of a group of chemical compounds known as cannabinoids. There are a lot of different cannabinoids out there. Researchers have identified over 113 so far, and are likely to find more in the future. CBD numbers just one of these 113. There is another cannabinoid that is more famous than CBD, which would be tetrahydrocannabinol (THC).  

THC is so famous because it is psychoactive. That means that it creates an inebriating high. It is not uncommon to think that because CBD and THC are both cannabinoids found in cannabis, CBD is also psychoactive. However, this is not a correct line of thought. CBD is not psychoactive. It may help its users achieve a greater sense of calm, but it will not cause any inebriating effect.  

CBD is generally taken from hemp, rather than marijuana. While they are both cannabis plants, they are variations of the plant. Hemp has high levels of CBD and low levels of THC. Meanwhile, marijuana has high levels of THC and varying degrees of CBD. CBD product manufacturers prefer hemp because it is easier to extract CBD from (due to the cannabinoid’s high levels) and more comfortable to keep THC out to the extract. Some CBD products do have THC in them, but it is less than 0.3%, which is not enough to cause any sort of high.  

There have been many studies looking into the different effects that CBD may have on people and the kind of help it may be able to provide. One area that has been looked at a lot is CBD’s effect on epileptic seizures. For example, this study asked parents of children with epilepsy to try giving their child some CBD-enriched cannabis. The researchers then asked the parents if they saw an improvement in the number of seizures that their children had. Most of the parents reported a drop in the name of seizures.  

Another study, published in 2017, looked at this same concept, but a bit more closely. The researchers induced seizures and other epileptic behaviors in rats. They then gave some of the rats CBD, while others were given none. They then observed the rats see how their rates of seizures and behavior changed. The rats that were given the CBD were recorded to have few seizures and reduced epileptic reactions.  

These studies, along with many others, have shown that CBD could be beneficial in keeping epileptic seizures to a minimum. As a result, the development of Epidiolex came about. It is a CBD based medication that is aimed at helping people (especially children) reduce the seizures that come along with two severe forms of epilepsy, Lennox-Gastaut and Dravet syndromes. In 2018, just before hemp was legalized in the United States, the FDA officially approved Epidiolex. After its approval by the FDA, the medication was then moved to a Schedule V designation by the Drug Enforcement Administration (DEA). But what exactly does that mean?

What does “Schedule V” mean? Why does Epidiolex get that title?  

When dealing with anything to do with cannabis, it is not unusual to see terms like “Schedule V.” But words like that can seem intimidating if you are unfamiliar with them. However, if you arm yourself with knowledge, you will soon see that a term like that is nothing to be afraid of.  

The FDA and the DEA have what is called Drug Scheduling. They use this to essentially classify how dangerous a substance is. There are five categories. The categorizing of a substance is based on how likely it for someone to abuse its use in a dangerous way. Schedule I is the highest level. It is reserved for substances like LSD and heroin that are classified as having no medical value, high abuse potential, and low safety margins. As the numbers of the scheduling get higher, the less serious the substance is considered to be. Meaning that Schedule V is considered to be the least dangerous of them all.  

Epidiolex is considered Schedule V because It is considered to be at low risk of being abused. This makes it no longer a controlled substance. That means that it is not heavily regulated by the government. This designation makes it easy (and legal) for doctors to prescribe Epidiolex, benefiting many people, especially children.  

What other CBD products are out there?  

Medication is not the only option if you are interested in trying CBD. There is a whole world of CBD products out there for people to try. So, let’s talk about what choices you have when looking for CBD.  

Edibles  

This is one of the most popular ways to take CBD. They are exactly what they sound like, food or drink that has been made with CBD. People tend to prefer edibles because they are easy to take and taste great. However, they do take a while for the CBD to start working. This is because the food/drink needs to digest before the CBD can enter the bloodstream and start working. They do also have the longest lasting effect. So, it is a bit of a tradeoff.  

Tinctures & oils  

Tinctures and oils are pretty simple. They are CBD extract that has been mixed with a carrier oil, like coconut oil. These are also a popular product because they offer a certain degree of flexibility. You can take oils and tinctures by mixing them in with food or drink. However, like with edibles, the food or drink needs to digest before the CBD can start its work. You can also take them by placing a few drops directly into your mouth. This is the faster option, especially if you place the drops under your tongue, as the skin under the tongue is thin. This allows the CBD to absorb into the system faster.  

Capsules & tablets  

If you are looking for a product that is more pill-like, these are the ones you should keep an eye out for. The capsules are the most pill-like and are usually soft gels. That means that they are made using liquid CBD extract. This makes it so that they digest faster and start working quicker. CBD tablets are a little bit different, but still a good option. They are usually sublingual, which means that you place them under your tongue and allow them to dissolve. Like with tinctures and oils, this allows the CBD to absorb into the bloodstream through the thin skin under the tongue.  

Topicals  

CBD topicals include anything that you use on your skin, rather than take orally. They can be lotions, salves, creams, balms, and hand sanitizers, among many other products. These are likely to give you a more localized effect, rather than the overall one you usually get from other CBD products. This is because the CBD never enters the bloodstream. Instead, the CBD in the topical absorbs through the pores on the skin. It does its work there but does not move much beyond where it is placed.  

Other FDA approved medications  

There are FDA approved medications that have CBD as one of the main active ingredients that are not Epidiolex or based around epilepsy at all. Most of them are for helping fight the nausea that is a common side effect of cancer treatments. Another one is called Sativex. That one is made to help combat the spastic pain that comes along with multiple sclerosis.  

As you can see, the Schedule V designation on Epidiolex is nothing more than a way of saying that it is considered to be safe overall by both the FDA and the DEA. There is still more research that needs to be done on CBD and CBD based medications. As time goes on it will be interesting to see what medications are approved by the FDA and the DEA.  

If you are curious about what else CBD has to offer, then check out the rest of our CBD blogs. We cover just about any questions that you may have about CBD. If those blogs do not answer your questions, then please feel free to reach out to us. You can contact us through our website or by emailing us at [email protected]. If you are ready to buy some CBD, then check out our wide range of products. We have something for just about everyone.

Reference Links:
Drug Scheduling
FDA-approved drug Epidiolex placed in schedule V of Controlled Substance Act