What Is Epidiolex & How Cannabis Medication Can Help
What is Epidiolex and why is it considered a groundbreaking medicine? There are several good reasons for it and we’ll go through the major ones. It belongs to a group of cannabis medications that are currently revolutionizing the world of medicine.
Cannabis has been praised for quite some time now and the research is backing up anecdotal evidence. Finally, several major pharmaceutical companies got the green light to place their cannabis medication on the market. Interestingly enough, while marijuana and its most famous compounds (CBD and THC) are familiar to the general public as a simple relaxation aid, the FDA-approved cannabis drugs are used to treat extreme conditions such as epilepsy, AIDS, and cancer.
Epidiolex is only the first FDA approved CBD oil-derived drug, paving the way for others to come. This is not just a success story, but a real heroic tale of parents fighting epilepsy and convincing a pharmaceutical giant to commence the production. Here are the glorious details on Epidiolex, as well as on some other available cannabis drugs such as Marinol, Sativex, Syndros, and Nabilone.
CBD Oil and Seizures: How Epidiolex Came to Be
Once upon a time, there was a 6-year-old boy. Sam Vogelstein has been struggling with epilepsy since he was 4 and by the time he turned 6, the seizures became more frequent and violent—up to 100 per day! Epilepsy statistics warn us of high mortality rates particularly due to the unpredictability of seizures. Sam was in constant danger of losing his life, especially after a few dangerous episodes.
Sam’s parents, Fred Vogelstein and Evelyn Nussenbaum, have tried every AED medication possible, the ketogenic diet, and applied every single piece of advice they received or read in literature.
Eventually, they heard about CBD and did thorough research on its benefits for seizures, reading all the literature they could find. Desperate for any improvement, they tried the CBD on their son, and it worked! The boy finally responded to the treatment and the seizures were minimized. His drug-resistant epilepsy seemed to be defeated.
However, there were issues with the CBD legal status in the US, as well as the fact that cannabis products are not FDA regulated. Consequently, the CBD amount in them constantly varies. For treating epilepsy, Sam Volgestein needed a regular, set dose of CBD.
Evelyn Nussenbaum came across GW Pharmaceuticals CBD. They had all the needed facilities for the production, including a cannabis sativa greenhouses. The parents managed to reach the company’s chairman, and the rest is history. Thanks to their endeavors, their son has been seizure-free for years and millions of other children have been given hope. Epidiolex is FDA-approved and available to epilepsy patients.
Now, let’s see what it says on the Epidiolex label.
The Basics of Epidiolex
What is Epidiolex in its essence? It is a strawberry-flavored, gluten-free CBD oral solution, white to pale yellow in color. Epidiolex contains 100mg/ml of CBD. As you may already be familiar with, CBD is one of the two basic cannabis compounds which does NOT get you high (that’s THC’s business). Its healing properties are numerous and it is already used for a variety of cases, though not all of them are officially recognized.
Besides CBD, Epidiolex ingredients comprise dehydrated alcohol, sucralose (artificial sweetener), and sesame seed oil. It’s not soluble in water. Basically, you can make your own CBD oil, though if you buy Epidiolex, you are absolutely sure about the ingredients, especially about THC percentage. This is one of the reasons for the success of pharmaceutically produced CBD and THC medicines.
Who makes Epidiolex in the US? Truth be told—no one. Epidiolex is imported from the UK. GW Pharmaceuticals is the British company behind it. Epidiolex is made from British cannabis (the cannabis sativa plant), while the US is (for now) just an importer. Interestingly enough, cannabis sativa, or hemp, has just become legal to produce in all states. Perhaps the US will soon become its own Epidiolex production.
What Is Epidiolex Used For?
It can be used by children over 2 years old and adults. The effects on children below this range are yet unknown. The types of epilepsy controlled by Epidiolex are very rare, yet extremely dangerous: Lennox-Gastaut syndrome and Dravet syndrome.
- Dravet syndrome can be diagnosed in the first year and is characterized by frequent seizures followed by fever. These later develop into other types of epileptic seizures, which can eventually lead to death. Dravet syndrome life expectancy rates range from 80% to 90%. Unfortunately, this means 10% to 20% of the sufferers don’t live into adulthood. The deaths usually occur before the patient is 10 years old.
- Lennox-Gastaut syndrome usually occurs in children between ages 3 and 5. Violent, frequent seizures have a hugely detrimental effect on a person’s physical and mental abilities. The majority of children suffering from Lennox-Gastaut syndrome have learning and motoric issues. Consequently, the quality of life is seriously impaired, requiring constant daily help.
Currently, the CBD drug is FDA-approved for only these two types of rare epilepsy.
What is Epidiolex’s future? We can expect it to be prescribed for two more rare conditions called tuberous sclerosis complex (TSC) and infantile spasms (IS).
- Tuberous sclerosis complex (TSC) is a serious genetic illness that is characterized by tumor growth all over the body. Most of the tumors are benign but they cause numerous health hazards. Over 90% of patients with tuberous sclerosis complex have epilepsy.
During a recent trial, almost 50% of patients aged 1–65 had their condition improved when CBD for seizures was added to their regular treatment. The trial was done in over 6 countries and at about 40 clinical sites. Reliable CBD research vouches that we can expect the drug to be approved for TSC very soon.
- Infantile spasms (IS) is a type of epilepsy that affects very young children, 4–8 months old. It is also known as West Syndrome. Due to seizures at such a young age, 70% of children develop psychiatric problems, hyperactivity, or cognitive delays. Cannabidiol effect has been tested and there are some promising yet unclear results. We still await for the more positive feedback to be published by GW Pharmaceuticals.
Epidiolex Side Effects
Just like any medication, Epidiolex has a sizeable list of potential side effects. For this reason, it can only be obtained through a doctor’s prescription and bought in pharmacies, not dispensaries. Also, this medicine is not for you if you are allergic to CBD! If you haven’t used it before, it would be wise to check for that first.
A person using Epidiolex for seizures may experience some of these side effects:
- Lower back pain or side pain
- Difficulties during urination
Less common Epidiolex side effects include:
- Difficulty breathing
- Anger and aggression
- Increased heart rate
- Loss of appetite
- Blue lips, fingernails, or skin
Some side effects such as rash, insomnia, or increased saliva may occur at the beginning and disappear later when the body gets used to the medicine. Consulting with the physician is obligatory, especially since Epidiolex is known to cause liver issues. Yellow skin or eyes are emergency warning signs. It also interacts with other drugs, especially the ones used for relaxation or sleep.
At the moment, Epidiolex is still being criticized for its high cost which makes it unavailable to a lot of people. However, when compared to its pharmaceutical competitors such as Fycompa, the price isn’t as large as it seems.
On average, the cost of Epidiolex is $32,500 per year. If you’ve got insurance, then the cost can be much lower. Thanks to the fact that Epidiolex is an FDA-approved CBD drug, insurance can cover for the costs (about $2,708 a month, $677 a week, or $96 a day).
Why is it then that the public is dissatisfied? The majority argues that the price is still too high. If Epidiolex is nothing much more than CBD oil, the difference between the medicine and a dispensary-purchased CBD bottle is extreme. For instance, a similar non-FDA-approved CBD oil could cost $3,840.
The Epidiolex price is still competitive, though, but only when medical insurance covers for it. Otherwise, it costs an arm and a leg, similarly to other epilepsy meds, and people usually tend to need several of them.
Why All the Hype?
There are other types of cannabis medication that are approved by the FDA. The FDA approves CBD in Epidiolex, and the world goes wild. The question is, why?
It is precisely the production process what has set a milestone in the CBD industry. Namely, in contrast to some other drugs, Epidiolex is made from CBD which is extracted from cannabis sativa plants. It is not synthetically produced in a lab.
One of the reasons for manufacturing a natural CBD drug may be due to the fact that our body does not process synthetic cannabinoids very well as opposed to natural ones. According to research, our inner endocannabinoid system fails to connect with artificial cannabinoids (be it CBD or THC). However, medicines with synthetic cannabinoids are in sales and are said to have healing properties, as we shall in the next section.
Other Notable Cannabis Medication
Besides Epidiolex, which is definitely the star of the medical marijuana industry show, there are some other marijuana-based medicines. Here are some other cannabis medicines which seem to be quite successful.
Dronabinol (Marinol, Syndros)
In its essence, Dronabinol is a drug that contains synthetically produced THC. Therefore, it is a pure form of THC and does not contain CBD.
Dronabinol is sold under two names: Marinol and Syndros, which have a similar effect. Both are made by Insys Therapeutics. Marinol and Syndros are FDA-approved. Marinol’s schedule, as well as Syndros’s, is III. Schedule III drugs are said to have low abuse potential. As a reminder, cannabis is still classified as a Schedule I drug.
Let’s take a look at their differences.
Marinol is basically Dronabinol in capsules. For better impact, THC is dissolved in sesame oil.
It is used to treat anorexia in patients with AIDS. Also, if common anti-nausea medicines don’t work during chemotherapy, cancer patients are prescribed Marinol. Marinol is not found to be effective in treating pain.
Marinol ingredients include sesame oil, so some of the side effects are related to an allergy to sesame oil. Others concern THC side effects: seizure, nausea, difficulty in making decisions, abdominal pain, and changes in blood pressure.
Marinol was approved by the FDA a long time ago—in 1985. Nevertheless, it is still classified as a Schedule III drug.
Syndros is the liquid form of Dronabinol. Therefore, this too is a synthetic cannabinoid.
It is prescribed for treating weight loss and improving appetite in patients with AIDS. Similarly to Marinol, this cannabis medication is used by cancer patients so as to deal with chemotherapy-induced nausea and vomiting that aren’t solved by other common medications.
What is more, there is some evidence that Syndros may be helpful in treating pain, but it is not officially approved for it. However, it seems that physicians prescribe it in cases when patients deal with pain and spasms too.
As for the side effects, these may include dizziness, nausea, stomach pain, hallucinations, mood changes, and inability to focus.
Syndros was approved by the FDA in July 2016. The medicine was the first liquid Dronabinol to get the green light.
In Europe, it is called Sativex. In the US, you may have heard the term Nabiximols, but this CBD medicine is yet to be approved for sale.
Sativex is an oromucosal spray with a THC to CBD ratio of 1:1. It also contains some minor cannabinoids and other components not related to cannabis.
It is manufactured by the same company that produces Epidiolex CBD— GW Pharmaceuticals. Hence, it is naturally extracted from cannabis sativa and not artificially made in a lab.
Sativex is used to treat muscle spasms and stiffness caused by MS. In addition, it is being researched as a treatment for schizophrenia and similar neurological diseases. The side effects include dry mouth, dizziness, fatigue, constipation or diarrhea, sleepiness, or memory problems.
Sativex is legal in 25 countries across the world and waiting for its approval in the US. The UK approved of its usage in 2010.
This cannabis medication goes by the brand name Cesamet. Once more, this is a synthetic form of THC. According to some resources, it is said to be twice as effective as natural THC. It is structurally different from THC but seems good enough to mimic its healing properties.
Nabilone or Cesamet capsules are used as medical marijuana to help cancer patients with nausea and vomiting caused by chemotherapy and AIDS patients who are losing weight rapidly. Other countries may approve of it for treating other conditions. For example, Nabilone is legal in Canada for treating chronic pain. Some studies suggest it could be mildly efficient for treating multiple sclerosis and fibromyalgia.
Cesamet side effects can include euphoria (feeling “high”), insomnia, headache, dizziness, fainting, mood and vision changes, paranoia, etc.
The drug was FDA approved back in 1985. However, the US sales did not take off until 2006.
What is Epidiolex going to be remembered by? In the history of marijuana books, it will be noted as the first “real” cannabis drug that got the FDA blessing. All other variants are artificially made in the laboratory and can never be 100% identical to natural extraction. There are pros and cons on both sides of the arguments, but the point is very simple, though. Epidiolex FDA approval is paving the way for similar cannabis drugs. Hopefully, we shall see the FDA regulating more valuable cannabis products soon enough.
What is the difference between Epidiolex and CBD oil?
Epidiolex has all the advantages of a pharmaceutically produced medicine. That implies that the ingredients are absolutely the same in every single bottle of Epidiolex. In contrast, CBD oil sold in dispensaries is not always of identical quality due to unregulated production facilities and government supervision. It is for this reason that GW Pharmaceuticals was approached in the first place.
What percentage of THC is in Epidiolex?
Epidiolex does not contain THC. It is a pure form of CBD oil. Epidiolex should not be confused with hemp-derived CBD oil which has up to 0.3% of THC. Even though Epidiolex is made from cannabis sativa, too, it hasn’t got the psychoactive ingredient.
What schedule is Epidiolex?
It is classified as a Schedule V drug. This is the lowest level for controlled substances. For example, cough medicines belong to this category.
Does Marinol get you high and does it show on a drug test?
Yes, Marinol can get you “high.” The elated feeling is listed as a side effect for all THC-based drugs. To this end, you can test positive on a drug test. However, it largely depends on what type of drug test you are taking. Some are easy to pass, while others are almost impossible.