Epilepsy and the First FDA-Approved Drug: Epidiolex

Patients, caregivers, and families of patients with severe forms of epilepsy rejoiced in late June 2018 when the U.S. Food and Drug Administration (FDA) finally approved a CBD-based medication called Epidiolex. It’s the first FDA-approved epilepsy medication that contains a pure substance derived from a marijuana plant.

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Epidiolex is a mouthful because of its name (why do pharmaceutical companies always do this?!) and because it’s taken orally. It’s been greenlighted to treat Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex (TSC) for patients at least one-year-old. Below, we explore the past and future of this promising drug as it makes a name for cannabis-based medical interventions.

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What is Epidiolex?

Epidiolex is an oral solution that is derived from CBD, or cannabidiol, from marijuana plants. More specifically, it is made from Cannabis sativa plants. Epidiolex has undergone rigorous FDA testing, unlike many other CBD oils you may see advertised on television or online that claim to treat just about every ailment under the sun.

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The medicine is also made partly from sesame oil and is usually strawberry-flavored. 

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Wait, did somebody say “strawberry”? As in, Strawberry Fields Forever? Nope! Epidiolex contains 0% THC, which is the ingredient in cannabis that causes euphoria and the classic high commonly associated with marijuana.

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Do you or your child have a strawberry allergy? Not to worry! Epidiolex only has strawberry flavoring — it’s not an effective way to get your daily servings of fruit. However, you should let your doctor know if the patient has allergies to sesame products. 

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It’s usually recommended to take Epidiolex with meals. Doctors often start patients at lower doses and gradually increase the amounts until an optimal amount is reached. Prescribed dosages are often based on the patient’s weight and the severity of the condition.

Who Makes Epidiolex?

Epidiolex is made by GW Pharmaceuticals, a British company. GW Pharmaceuticals is a subsidiary of Jazz Pharmaceuticals, which was founded in California in 2005 and has been based in Ireland since 2012. 

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Besides the three conditions treated by Epidiolex, GW Pharmaceuticals, which was formed in 1998, also makes Sativex, a drug that treats several symptoms of multiple sclerosis. Unlike Sativex, Epidiolex does not have a generic alternative.

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You probably cannot find Epidiolex at CVS, Walgreens, or your neighborhood pharmacy. This drug can instead be accessed at many long-term care or specialty pharmacies.

Charlotte’s Web CBD

Epidiolex — and just about any cannabis-related medication currently in use in the U.S. — owes much to Charlotte’s Web CBD and the pioneering efforts of Paige Figi. 

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Paige’s daughter, Charlotte, had a condition known as Dravet syndrome. Despite her young age, Charlotte experienced more than 40 grand mal seizures per day.  Paige began experimenting with CBD oil derived from a plant that later became known as Charlotte’s Web.

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After refining the strain with the help of the Stanley brothers in Colorado, Charlotte’s web CBD oil was introduced to the public in 2013. Charlotte went from 40 seizures per day to two or three per month. 

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The media attention garnered by this relatively new epilepsy treatment helped pave the way for understanding and acceptance of various cannabis-based treatments. We arguably wouldn’t be where we are today in our understanding of cannabis as a natural medicine without Charlotte!

How Does Epidiolex Work?

Epidiolex is thought to work by binding to most of the same brain receptors targeted by other CBD oils and medications. To enter the body, the patient must measure the exact amount prescribed by their doctor and place it in the syringe provided with the medication. Don’t worry — no needles are involved here!

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Instead of placing Epidiolex on the back of the tongue as you might with other oral medications, gently pump the medicine inside your cheek to avoid choking. Swallow the solution when you’re ready. It’s best to store Epidiolex at room temperature, away from moisture.

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Once it goes down your gullet, a number of incredible things start happening — some of which are not yet fully understood by science. It’s believed that CBD oil interacts with the brain’s endocannabinoid system, which is a complex system of neurotransmitters and receptors. Everyone has an endocannabinoid system, even if they’ve never touched marijuana, CBD, or hemp products.

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Scientists don’t have an exact answer for how Epidiolex and other CBD medications exert their influence on the endocannabinoid system, but they may connect with CB1 and CB2 receptors. Your CB1 receptors mostly hang out in your brain and central nervous system; they help regulate things like pain, appetite, sleep, and metabolism. CB2 receptors are thought to help regulate the immune system and inflammation.

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The anti-convulsant effects of Epidiolex may take a few days or weeks to make a noticeable difference. It could take a while for the medication to get acquainted with the endlessly complex systems jumping around in the brain and central nervous system.

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Are you a little unnerved by the fact that scientists don’t know exactly how and why Epidiolex and CBD oil can help reduce seizures in some people? We understand the feeling. However, Epidiolex has undergone the same approval process as some of the most effective medicines used worldwide. 

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Also, fun fact: Scientists aren’t exactly sure how acetaminophen (Tylenol) helps reduce pain for many people or how penicillin fights infection. And those two drugs have been around a lot longer than Epidiolex! While it’s nice to know everything you can about the drugs you put in your body, it’s likely even better to have relief from a nagging headache or bothersome abscessed tooth.

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Whatever questions you have about your medications, the best resource is a doctor you know and trust. If any medical professional makes you feel dumb for asking questions, run the other way!

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Does Epidiolex Have Side Effects?

Like many medications, Epidiolex carries the possibility of one or more unpleasant or uncomfortable side effects. Potential Epidiolex side effects may include:

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• Drowsiness
• Fatigue (decreased energy)
• Malaise (feeling unwell)
• Weakness or feelings of weakness
• Decreased appetite
• Mild rash
• Increased risk of infections
• Insomnia or other sleep disturbances

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The side effects listed above are more common than others. They may appear when you begin taking Epidiolex or after sustained use. They might go away after your body gets used to the drug. 

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If these side effects become too uncomfortable, let your doctor know. They may tweak your dosage or have you try another medication. However, your doctor may encourage you to keep taking Epidiolex if they believe the benefits outweigh the side effects.

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A few possible side effects from Epidiolex, however, should be reported to your doctor as soon as possible. These potentially serious side effects are:

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• Sedation or loss of consciousness
• Trouble thinking
• Coordination problems
• Serious allergic reaction
• Suicidal thoughts*
• Liver problems, including (but not limited to) nausea, vomiting, or jaundice

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*If you or someone you know may be having suicidal thoughts or ideations, please consider contacting the National Suicide & Crisis Lifeline. You can do this by calling or texting 988.

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Doctors often keep a close watch on the liver enzymes of someone taking Epidiolex. This can usually be accomplished by periodic blood testing. Epidiolex may interact with other anti-seizure medications; as always, please let your doctor know about all other substances you’re taking — including over-the-counter drugs.

Interested in Taking the Next Step?

Countless patients have seen a decreased amount of epileptic seizures after beginning Epidiolex. 

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The first step in seeing if it can benefit you or your child is to start a conversation with a trusted doctor. They may have reasons to encourage you not to start on Epidiolex immediately or to try a similar drug. 

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If you start taking Epidiolex and don’t see any improvements, try to hang in there — scientists regularly make discoveries about CBD, anti-seizure medications, and so many other aspects of epilepsy.

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If you want to learn more about CBD and its potential health benefits, head over to The Green Dragon’s education page. We explain how it may help numerous conditions, including stress, insomnia, pain, and brain fog. We also invite you to peruse our shop to see if any CBD products catch your eye. 

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Good luck, and happy medicating!