Epidiolex Vs CBD Oil

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Epidiolex is an FDA-approved cannabidiol (CBD) based oral solution used for the treatment of seizures in those with Dravet and Lennox-Gastaut syndrome. FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

What Is Epidiolex?

Epidiolex is an oral solution containing cannabidiol (CBD). It is available on prescription in the US to treat seizures in Dravet syndrome, Lennox-Gastaut syndrome (LGS), or tuberous sclerosis complex (TSC) in those ages one and older. A systematic review including human clinical trials concludes that using oral CBD is associated with reducing seizure frequency in those with Dravet or LGS.

What Is Epidiolex?

Epidiolex is a pharmaceutical-grade CBD oral solution. It is a clear, colorless-to-yellow liquid containing CBD at a concentration of 100 milligrams per milliliter (100 mg/mL). Other ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.

Epidiolex is the first FDA-approved cannabis-based medication in the US, initially for treating seizures in treatment-resistant forms of Dravet syndrome and LGS. Phase 3 clinical trials were initiated in 2015, and the FDA approved Epidiolex in June 2018. The trials showed a positive result in reducing seizures in children with Dravet syndrome and LGS.

Epidiolex is approved for those with treatment-resistant seizures associated with Dravet, LGS, or tuberous sclerosis complex, but physicians may prescribe it off-label for other conditions.

Epidiolex is made with CBD derived from cannabis instead of being a synthetic cannabinoid. Epidiolex is a 99% pure oral CBD extract and does not contain tetrahydrocannabinol (THC), other cannabinoids, or terpenes.

Epidiolex vs. CBD Oil

Patients have a common question: “Are CBD oil and Epidiolex the same thing?” The answer is “No.”

When people talk about CBD oil, they usually refer to hemp-derived CBD oil that is legally available on the market. However, this is not approved for use for any particular medical condition by the FDA. CBD oils can be CBD-only (CBD isolates), broad-spectrum (CBD and terpenes, with no THC), or full-spectrum (CBD, terpenes, and up to 0.3% THC). Their quality is variable, and how accurate their labels are regarding cannabinoid content is up for debate (i.e., there is no standardization of hemp products).

Although 0.3% THC may not seem like much in theory, it may end up being up to 3 mg of THC per 1000 mg (gram) of product. Again, not necessarily a lot for many, but it can affect some who might be particularly sensitive to THC or need specific, extremely low doses. If large doses are required for any effect in a non-pharmaceutical product (e.g., three 30 ml bottles per day), this can end up being a larger amount of THC being ingested. This can cause great variability in a product’s effects. The fact that so many products are inaccurate in their THC and CBD measurements complicates matters further.

Indeed, one study shows that people who used artisanal CBD had a 70% increase in seizures, whereas people utilizing pharmaceutical-grade CBD showed a reduction in seizures. Although the study’s sample size was small (only 31 people), it is worth bearing in mind that the variability of non-regulated, hemp-derived CBD products and the cannabinoids and terpenes in them play a part in determining what effect they have when ingested.

Uses and Health Benefits

CBD has displayed anti-inflammatory properties on top of its well-established anti-seizure properties, making it helpful in treating many different health problems. But we cannot say whether or not CBD is beneficial for health beyond those established by scientific research.

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Adverse Side Effects

Adverse side-effects of Epidiolex can include, but are not limited to:

  • Sedation and sleepiness
  • Fatigue
  • Sleep problems
  • Rash
  • Decreased appetite
  • Nausea and vomiting
  • Diarrhea
  • Fever
  • Infections
  • An increase in liver enzymes
  • Negative interactions with other anti-seizure medications

Potential Interactions

CBD may interact with the following antiepileptic drugs (AEDs):

  • Clobazam
  • Stiripentol
  • Valproic acid and sodium valproate
  • Topiramate
  • Eslicarbazepine
  • Zonisamide
  • Brivaracetam
  • Gabapentin
  • Pregabalin

CBD and medical cannabis may also interact with sedatives and antihistamines with sedative properties like zolpidem (Ambien), eszopiclone (Lunesta), and diphenhydramine (Benadryl). Anti-anxiety medications and antidepressants as well, like alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), sertraline (Zoloft), fluoxetine (Prozac), and escitalopram (Lexapro). CBD may also interact with blood thinners like warfarin.

Frequently Asked Questions

Is Epidiolex the same as CBD oil?

No, they are not. Epidiolex is FDA-approved and is a pharmaceutical product produced by Greenwich, a subsidiary of GW Pharmaceuticals. CBD oil is not a pharmaceutical product and is not available for prescription, and is not approved for any medical use by the FDA. Although Epidiolex uses cannabis plants for its CBD, the product is made to a different standard compared to hemp-derived CBD oils.

Is Epidiolex a narcotic?

The DEA has descheduled Epidiolex and is not legally considered a “narcotic.” CBD does, however, have psychoactive effects, even if they’re not necessarily intoxicating or psychotropic in the same way THC is. CBD and THC are different compounds and affect the endocannabinoid system (ECS) differently.

In 2019, the Legislature formally rescheduled Epidiolex as a Schedule V controlled substance. On April 6, 2020, the DEA descheduled Epidiolex entirely, meaning it is no longer subject to the Controlled Substances Act (CSA) and its tracking and monitoring requirements. You are legally permitted to cross state lines in the US with Epidiolex in your possession.

Do you need a prescription to get Epidiolex?

Yes, you will need a prescription to purchase Epidiolex, and you will need to find a specialty pharmacy, too. More information can be found here.

Is it possible to test positive for marijuana when using Epidiolex?

There is the possibility of testing positive for marijuana metabolites on urine drug screenings due to Epidiolex use. However, technically this should be unlikely as most drug screenings do not test for CBD. Patients/caregivers should inform the drug testing site that they have a prescription for Epidiolex from their doctor.

Can I or my child get addicted to Epidiolex?

Current research suggests that CBD is not addictive.

Can I drive under the influence of Epidiolex?

Some people may feel sleepy after consuming Epidiolex (especially if combined with other AEDs, anti-anxiety medications, or alcohol), so it is not advisable to drive if such effects are felt. Many people develop a tolerance to the sedative effects of CBD after taking it for some time so that the sedative effects may subside over time.

Once you start understanding how Epidiolex affects you after ingestion, you can judge what you can do with it for yourself.

Article written by

Dipak Hemraj Head of Research and Education

Dipak Hemraj is a published author, grower, product maker, and Leafwell’s resident cannabis expert. From botany & horticulture to culture and economics, he wishes to help educate the public on why cannabis is medicine (or a “pharmacy in a plant”) and how it can be used to treat a plethora of health problems. Dipak wants to unlock the power of the plant, and see if there are specific cannabinoid-terpene-flavonoid profiles suitable for different conditions.

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FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).

It is THC (and not CBD) that is the primary psychoactive component of marijuana.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.

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Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.

The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.

Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD.

The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.

The FDA granted Priority Review designation for this application. Fast-Track designation was granted for Dravet syndrome. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications.

The FDA granted approval of Epidiolex to GW Research Ltd.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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