Epidiolex Vs CBD Oil

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Epidiolex (Cannabidiol) Primer: Frequently Asked Questions for Patients and Caregivers On June 25, 2018, the first plant-derived, purified pharmaceutical-grade cannabidiol (CBD) medication, Epidiolex is a CBD-based pharmaceutical prescribed to treat epilepsy. Is it the same as CBD oil? Apparently not. Let’s dive into the differences between Epidiolex and CBD oil. 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.

Epidiolex (Cannabidiol) Primer: Frequently Asked Questions for Patients and Caregivers

On June 25, 2018, the first plant-derived, purified pharmaceutical-grade cannabidiol (CBD) medication, Epidiolex (Greenwich Biosciences Inc, Carlsbad, CA), was approved in the United States by the US Food and Drug Administration (FDA). Epidiolex is for patients 2 years and older with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS), and has revolutionized the treatment of medically refractory seizures in these patients. 1 – 4 The road to widespread therapeutic use of CBD and its recent approval for seizure disorders has been a long one. 1 – 4

Four pivotal randomized, double-blind, multicenter clinical trials evaluated the use of CBD in patients with DS and LGS with regard to the efficacy and safety in convulsive and drop seizure, respectively (GWPCARE 1–4). 4 All trials demonstrated a significant absolute reduction in seizure frequency. 1 – 4 The most common adverse drug effects (≥10%) depicted in the trials included somnolence, fatigue, rash, decreased appetite, diarrhea, insomnia, infection, and elevated transaminases. 1 – 4

Epidiolex is a CBD-only component, with no Δ 9 tetrahydrocannabinol [Δ 9 THC]. 1 THC is the psychoactive component of cannabis, responsible for appetite stimulation and a euphoria sensation. 5 , 6 When referring to cannabis it is a collective term for 3 species of hemp plants, including Cannabis sativa, Cannabis indica, and Cannabis ruderalis. 5 , 6 Both THC and CBD are considered phytocannabinoids, which are chemicals within cannabis that may interact with the cannabinoid receptor. 5 , 6 Although the exact mechanism of action is unknown, both CBD and THC are thought to be efficacious in their role for pediatric epilepsy. 5 , 6 Using the non-psychoactive component, CBD, allows patients to have few side psychoactive side effects while still having the benefit of reduction in seizure frequency. 6 There are other cannabidiol products currently on the market, including hemp oil. Hemp oil is federally legal and contains less than or equal to 0.3% THC and is hemp derived. It can be bought over the counter at pharmacies, grocery stores, and even gas stations. 7 Some states allow patients or caregivers to possess CBD products greater than 5% with a state permit. 7 Although it is becoming increasingly common to see patients on hemp oil because of the ease of access, it is important to recognize that none of these products are FDA approved and have efficacy data in relation to seizures. 7 The FDA has released a statement saying it is “aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk.” 8 The Table below contains a list of frequently asked questions regarding Epidiolex.

Table.

Epidiolex (Cannabidiol): Frequently Asked Questions for Patients and Caregivers

Question Response
What is Epidiolex? It is an FDA-approved, plant-derived, purified prescription cannabidiol, indicated for the treatment of seizures in patients 2 years and older. 9
Is a state permit required for Epidiolex? No, it is an FDA-approved prescription medication (Schedule V), making it legal under federal law; therefore, no state permit is necessary.
Are cannabidiol and marijuana the same thing? No, CBD is derived from the cannabis (marijuana) plant; however, it is entirely different from marijuana and has none of the euphoric properties or abuse potential. CBD and THC are the 2 most frequent chemicals found in the plant.
Does Epidiolex contain THC? No. However, other CBD, “hemp,” and medical marijuana products available may contain small amounts of THC. These products are not regulated; therefore, there is variability in how much THC has been removed from these products and how much CBD is in these products.
Are Epidiolex and CBD the same thing? Epidiolex is the brand name for the pharmaceutical-grade cannabidiol oil product produced by Greenwich, whereas other CBD, “hemp,” and medical marijuana products available may contain small amounts of THC. These products are not regulated; hence, there is variability in how much THC has been removed from these products and how much CBD is in these products.
Is it possible to test positive for marijuana while on this drug? While on Epidiolex, patients may test positive on urine drug screenings. Patients/parents should inform the drug testing site that they are taking Epidiolex as prescribed by their doctor.
Will Epidiolex cause my child to have euphoria-like experiences (i.e., the “high”)? No, Epidiolex will not create euphoric effects because it does not contain any THC, which is the chemical compound in marijuana that creates the “high” effect.
Can my child become addicted to Epidiolex? No
How is Epidiolex formulated? Epidiolex comes in a strawberry-flavored, sesame oil–based oral solution.

CBD, cannabidiol; FDA, US Food and Drug Administration; THC, tetrahydrocannabinol

Table.

Epidiolex (Cannabidiol): Frequently Asked Questions for Patients and Caregivers (cont.)

Question Response
If my child is allergic to strawberries or sesame seeds, can they take Epidiolex? Epidiolex can be given to patients with strawberry allergies because it only contains strawberry flavoring. However, as with any allergy, it is important to discuss with your child’s physician first. Epidiolex is not recommended for patients who have a sesame seed allergy because Epidiolex is made in sesame oil.
How should Epidiolex be stored? It should be stored at room temperature and can be used within 12 weeks of opening. It is important to throw away any remaining medication after 12 weeks.
Does Epidiolex interact with my child’s other medications? There is a possibility that Epidiolex may interact with other prescription, non-prescription, and herbal medications that your child may be taking. Please speak to your doctor or pharmacist before starting this medication. You should also make sure they are aware anytime you add a new prescription or non-prescription drug. If you have any questions regarding other medications, talk to your doctor or pharmacist.
How is Epidiolex given? It is given twice daily and is dosed based on your child’s weight. It is important that Epidiolex be given consistently with meals and given around the same time each day.
Can Epidiolex be given with food? Although Epidiolex can be given with or without food, it is preferred that it be given with meals.
Can Epidiolex be administered through a gastrostomy (G-tube)? Yes; however, the G-tube should be flushed well. Give Epidiolex first, followed with water, then give some formula, and follow with water to flush the G-tube well. Please discuss this with your physician. (Greenwich Biosciences Inc., written communication, June 12, 2019).
Is Epidiolex compatible with my child’s ketogenic diet? Yes. It may be given to your child if they are on the ketogenic diet. You should discuss with your doctor, dietitian, or pharmacist about your dietary therapies and any changes before starting Epidiolex.
What are the most common side effects of Epidiolex that my child may experience? The most common reported side effects include drowsiness, diarrhea, decreased appetite, lack of energy, sleep problems, increased liver enzymes, and infections.
Can my child overdose on Epidiolex? As with any medication, overdoses or taking more than prescribed by your child’s doctor can be harmful. If you suspect an overdose, accidental or not, please call your physician or poison control at (800) 222–1222.
Where can I get Epidiolex? Epidiolex is only dispensed through specialty pharmacies. Someone from the pharmacy will verify your child’s prescription and work with your insurance company.
Will medical insurance cover Epidiolex? Yes, most plans do. There is an approval process that can take days to a few weeks. It is approved for patients 2 years and older with a diagnosis of Lennox-Gastaut syndrome or Dravet syndrome.
Is there financial or patient support for Epidiolex? The manufacturer has a support program. “Epidiolex Engage” includes an Epidiolex Copay Savings Program. Talk to your doctor or pharmacist should you have any concerns about affording your medications. https://www.epidiolex.com/engage-patient-support/assistance
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CBD, cannabidiol; FDA, US Food and Drug Administration; THC, tetrahydrocannabinol

Footnotes

Disclosure The authors declare no conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.

REFERENCES

2. Devinsky O, Cross JH, Laux L et al. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome (GWPCARE1) N Engl J Med. 2017; 376 (21):2011–2020. [PubMed] [Google Scholar]

3. Devinsky O, Patel AD, Cross JH et al. Effect of cannabidiol on drop seizures in the Lennox-Gastaut syndrome (GWPCARE3) N Engl J Med. 2018; 378 (20):1888–1897. [PubMed] [Google Scholar]

4. Thiele EA, Marsh ED, French JA et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018; 391 (10125):1085–1096. [PubMed] [Google Scholar]

5. O’Connell BK, Gloss D, Devinsky O. Cannabinoids in treatment-resistant epilepsy: a review. Epilepsy Behav. 2016; 70 (pt B):341–348. [PubMed] [Google Scholar]

6. Campbell CT, Phillips MS, Manasco K. Cannabinoids in Pediatrics. J Pediatr Pharmacol Ther. 2017; 22 (3):176–185. [PMC free article] [PubMed] [Google Scholar]

7. Perucca E. Cannabinoids in the treatment of epilepsy. J Epilepsy Res. 2017; 7 (2):61–76. [PMC free article] [PubMed] [Google Scholar]

8. 2018 Farm bill legalizes hemp, but obstacles to sale of CBD products remain. The National Law Review. 2019 Mar 5; https://www.natlawreview.com/article/2018-farm-bill-legalizes-hemp-obstacles-to-sale-cbd-products-remain Accessed June 19, 2019.

9. FDA Regulation of cannabis and cannabis-derived products, including cannabidiol (CBD) US Food and Drug Administration Web site. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd Accessed October 12, 2019.

Articles from The Journal of Pediatric Pharmacology and Therapeutics : JPPT are provided here courtesy of Pediatric Pharmacology Advocacy Group

CBD Oil vs Epidiolex — Which Is Better for Epilepsy?

The approval of Epidiolex in June 2018 signified a turning point in the treatment and management of seizures. Since the FDA-approved drug has CBD as its major component, its inclusion into the medical space as a prescription drug convinced even CBD’s skeptics of its potential

However, are Epidiolex and CBD Oil the same?

Proponents assume that since both products contain Cannabidiol, they must have the same uses. However, ongoing research does not support this claim.

This article seeks to spell out the differences between Epidiolex and CBD Oil, their principal pharmacological effects, side effects, and how best to increase the former and subdue the latter.

About Epilepsy

Epilepsy is a chronic non-communicable disease of the nervous system that affects about 50 million people worldwide. The condition is marked by unprovoked seizures, during which an individual loses voluntary control of the entire body or just a part of the body.

One seizure does not make an epileptic. According to the World Health Organisation, an individual must have had at least two seizures in his lifetime to be diagnosed with epilepsy. Epilepsy is a sensitive condition; the risk of premature death in epileptics is three times that of an average person. Statistics declare that 70% of epileptics can live seizure-free with proper management.

Common medications used to manage epilepsy include anti-epileptic drugs (AEDs) such as Clonazepam, Diazepam, Valproic acid, which usually present with side effects like lack of energy, drowsiness, tremors, headaches, and hair loss.

CBD is a potent anti-seizure medication that has found its use in some particular kinds of epilepsy; the drug-resistant Dravet Syndrome, Lennox-Gastaut Syndrome which plagues infants, and in Tuberculosis Sclerosis Complex. CBD products present with milder side effects than typical AEDs and are much more tolerable.

The only FDA-approved brand of CBD for managing seizures is Epidiolex. Nonetheless, other formulations containing organically-sourced CBD will have similar effects on seizures. The potency of CBD Oil against a seizure is dependent on its dose, form, and preparation.

What is CBD?

CBD stands for cannabidiol. It’s one of the cannabinoids found in the Cannabis Sativa plant. CBD is not psychoactive like tetrahydrocannabinol (THC), its sister component. This makes it more appealing when it comes to relieving pain and other symptoms without psychoactive side effects, and is suitable for children above the age of two.

Cannabidiol is one of the most active ingredients of medical cannabis, second only to THC. You can derive it directly from the marijuana flowers, or by using larger amounts of hemp plants. It can also be manufactured in a laboratory. Cannabidiol comes in different forms such as oils, vapes, creams, extracts, and capsules.

Research on human and animals have suggested some benefits of CBD such as:

  • Anti-seizure properties
  • Neuroprotective effects
  • Anti-acne and Anti-inflammatory
  • Anti-cancer
  • Fights anxiety disorders
  • Lowers cravings for tobacco and heroin
  • Lowers high blood pressure
  • Improves sleep

What is Epidiolex?

Epidiolex is an extract from cannabis that contains 99% CBD that has been purified and is prescribed for medical purposes.

Although it contains no THC, as of 2018, it was placed on the list of controlled drugs and classified as a Schedule V prescription drug. This means that the regulatory body suspected that the drug may be subject to misuse by individuals seeking the psychoactive effects of THC.

As of 2020, Epidiolex was taken off the controlled drugs list, and pharmacists were free to dispense without retaining the prescription. Epidiolex remains a prescription-only drug. However, this legislation makes it easier to refill when it runs out.

Ingredients of Epidiolex

The formula of Epidiolex includes the following ingredients:

  1. Cannabidiol: the exact mechanism through which cannabidiol halts seizures remain unknown to scientists. One proposed mechanism involves the activation of the CB1 receptors of the endocannabinoid system, which are concentrated in the brain, and sparsely distributed in the periphery.
  2. Sucralose: Sucralose is an artificial sweetener. It has almost no calories and is 600 times sweeter than real sugar. Sucralose is used in ice cream and yogurt.
  3. Sesame seed oil: Sesame oil is edible vegetable oil. It is derived from sesame seeds. Sesame oil contains omega-3 and omega-6 fatty acids. It provides the benefit of protecting skin from sunburn and managing inflammation.

What is CBD Oil?

CBD oil is a viscous extract with high concentrations of CBD. The extract is diluted in a carrier oil, such as MCT oil or hemp seed oil to improve its bioavailability and speed up absorption. People use it for daily supplementation as well as to treat or manage the aforementioned health conditions.

Ingredients of CBD Oil

These are the following main ingredients:

  1. Hemp: A hemp flower is an unprocessed bud from the hemp plant. Hemp has a higher concentration of cannabidiol and a lower level of tetrahydrocannabinol.
  2. MCT Oil: MCT oil is a supplement made from medium-chain triglycerides. It is easily oxidized and breaks down rapidly to release energy. The oil, which can be found in coconut and palm oil, is rich in antioxidants and anti-inflammatory effects by activating neutrophils and mitochondrial reprogramming.
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Comparing CBD Oil and Epidiolex: Epilepsy Treatment

Epidiolex in the Treatment of Epilepsy

Epidiolex is the first FDA-approved drug that is a CBD-derived medication for the treatment of epilepsy.

The FDA approved Epidiolex for the treatment of two severe and rare forms of epilepsy in patients two years of age and older — Lennox-Gastraut syndrome and Dravet syndrome. Epidiolex is also approved to treat seizures associated with tuberous sclerosis complex.

The job of the FDA is to protect public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical services. First of all, the manufacturers of a product conduct laboratory, animal, and clinical testing. Then, the FDA reviews the results of the testing and grants approval.

Three clinical trials involving 516 patients with Lennox-Gastaut syndrome and Dravet syndrome studied the effectiveness of Epidiolex. In one of these trials, Epidiolex was combined with other anti-seizure medications. Compared to a placebo, Epidiolex was more effective in the reduction of seizures.

CBD Oil in the Treatment of Epilepsy

CBD oil is a mixture of Cannabidiol with a carrier oil. CBD oils that contain other compounds such as supportive cannabinoids, terpenes, and traces of THC are labeled as full-spectrum by manufacturers. The presence of these supporting compounds boosts the effect of CBD, a mechanism called the entourage effect. This phenomenon doesn’t occur in the highly purified Epidiolex.

CBD oil may help in treating some seizure symptoms but it has some side effects. CBD Oil typically comes as a tincture, with a dosage of 25-50mg of CBD per ml. The CBD market isn’t regulated like the pharmaceutical industry, so there’s no standardization among products, both when it comes to potency and purity. Therefore, it’s difficult to evaluate the efficacy of specific dosages.

More research still needs to be carried out to understand the risks and benefits of CBD oil.

Which is Better in the Treatment of Epilepsy?

The option of Epidiolex and CBD Oil gives patients and caretakers a chance to individualize their regimen. The best pick would depend on each patient’s individual circumstances.

CBD oil has a broader spectrum of activity and fewer side effects. It may treat other coexisting conditions such as acne and inflammation, as opposed to the rash occasionally associated with Epidiolex use. Even so, always consider the effect of seizure relief. At the appropriate dosage, CBD Oil is just as potent as Epidiolex.

What to Consider When Choosing Between Epidiolex vs CBD Oil

Regulations

The FDA is yet to approve any commercial CBD brands for the treatment of epilepsy. Epidiolex is a prescribed drug that has gone through well-controlled clinical trials, has been reviewed and approved by the Food and Drug Administration (FDA) to treat Lennox-Gastraut and Davet syndrome. You may get a prescription for Epidiolex, and purchase it at the nearest pharmacy.

CBD oils are recommended by doctors and can be purchased from online or physical stores. You don’t need a prescription for such products.

Safety

FDA studies suggest Epidiolex has been proven to be safe. Epidiolex is a cannabis extract made up of 99% CBD that has been purified. It also contains no tetrahydrocannabinol. THC is a principal psychoactive component of cannabis with a “high” effect.

CBD oil may contain other cannabinoid compounds and some contaminants. The FDA does not regulate CBD products, so CBD oils are not proven to be safe. The concentration of THC may vary with the brand.

Effectiveness

According to Dr. Devinsky, a professor of neurology, neurosurgery, and psychiatry at the NYU Grossman school of medicine and director of NYU Langone’s Comprehensive Epilepsy Center, “The approval of Epidiolex or cannabidiol is a landmark in medicine. It is the first time such a medication, based on a cannabis plant, has been approved and scientifically established to be an effective treatment in the United States.” The pharmacological actions of CBD are not fully understood. However, Dr. Devinsky says, “We do understand some of how it helps to control seizures (by working) on a receptor system that no other drug touches.”

More research still needs to be carried out to understand the effectiveness of CBD oil.

Side Effects

Clinical trials carried out on Epidiolex suggest significant side effects were experienced by some of the participants like fever, vomiting, diarrhea, lethargy, fatigue, and drowsiness. Epidiolex may also lead to a change in liver function, jaundice, unusual darkening of the urine, and right upper abdominal pain.

CBD, the main component of CBD oil, is well-tolerated and its effects are considered mild Some of these adverse reactions include abnormalities in liver function, drowsiness, diarrhea, and dry mouth. In some studies, some patients experienced an increase in seizures with CBD. CBD Oil may interact with other medications, such as blood thinners.

Affordability

It can be expensive to purchase Epidiolex. However, insurance may cover it in certain regions. The Epidiolex Copay Savings Program is eligible to legal residents of the United States or Puerto Rico. Some people who lack access to these privileges opt to buy CBD products from stores as an OTC alternative.

How to Use Epidiolex vs CBD oil

How to Use Epidiolex

Epidiolex is a liquid pharmacological drug. It is administered orally. The required dosage of Epidiolex depends on body weight and symptom severity.

The dosage based on a child’s body weight:

  1. Starting dosage: 2.5 milligrams per kilogram (mg/kg) taken twice daily per oral.
  2. Maintenance dosage: 5 mg/kg taken twice daily per oral.
  3. Maximum dosage: 10 mg/kg taken twice daily per oral.

How to use CBD oil

Most CBD oils come in bottles with a dropper. There are no guidelines for the proper administration but there are methods of using CBD oil. CBD oil is administered sublingually. place a few drops under the tongue and retain for 30 to 60 seconds without swallowing. The dose may be 5mg-25mg daily depending on what you are treating.

Interactions Between CBD and Medications

Certain side effects may occur when CBD is used with other drugs and medications such as:

  • Antipsychotics
  • Benzodiazepines
  • Clonazepam
  • Fluoxetine
  • Erythromycin
  • Clarithromycin
  • Calcium channel blockers
  • Carbamazepine
  • Ketoconazole
  • Fentanyl
  • Rifampin

CBD inhibits some enzymes of the large family of CYP450 and alters the way they metabolize certain drugs. It’s a similar mechanism to the one demonstrated by grapefruit juice. When taken together with other medications, CBD may either decrease or increase its concentration in the bloodstream — leading to toxicity or subtherapeutic effects depending on the type of interaction.

If you take any medications, talk to your doctor before adding CBD oil to your routine. Doing so will help you find the right timing for both compounds, as well as the dose to avoid interactions.

Key Takeaways on CBD vs Epidiolex

The major difference between the purified and FDA-approved Epidiolex and CBD Oil brands is that Epidiolex contains 99% CBD and no other cannabinoids. CBD oils, on the other hand, contain supportive cannabinoids that enhance their pharmacological activity. On the flip side, CBD Oils may contain contaminants and psychoactive compounds if they’re improperly manufactured and not tested by a third-party laboratory.

CBD oils also vary in terms of potency, appearance, and taste, based on brand. This may be desirable when a wider range of options positively affects treatment results.

People now have the choice of using Epidiolex or CBD oil to treat epilepsy. You need to know what they are and how they work before choosing your treatment option. If you would like to explore the prescribed medication, Epidiolex, or store-bought CBD oil, talk to your doctor first.

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Sources:

  1. Esposito, L. (2020), CBD Oil for Treating Epilepsy, U.S News and World Report L.P.
  2. FDA, (2018), FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy, FDA News Release.
  3. Iffland, K., Grotenhermen, F. (2017), An Update on Safety and Side effects of Cannabidiol: a Review of Clinical Data and Relevant Animal Studies, Mary Ann Liebert, Inc. 2(1), 139-154.
  4. World Health Organization (2022). Epilepsy. WHO.int. Retrieved from: [1]
  5. Abu-Sawwa, R., & Stehling, C. (2020). Epidiolex (Cannabidiol) Primer: Frequently Asked Questions for Patients and Caregivers. The journal of pediatric pharmacology and therapeutics: JPPT: the official journal of PPAG, 25(1), 75–77. [2]
  6. Martinez, M. (2021). CBD May Help People with Epilepsy Better Tolerate Anti-Epilepsy Medications. John’s Hopkins Medicine. Retrieved from: [3]
  7. Yu, Go, & Kim. (2019). Medium Chain Triglyceride (MCT) Oil Affects the Immunophenotype via Reprogramming of Mitochondrial Respiration in Murine Macrophages. Foods, 8(11), 553. [4]
  8. Singh, J., & Antimisiaris, M. F. (2020). Epidiolex-induced skin rash. Epileptic disorders: international epilepsy journal with videotape, 22(4), 511–514. https://doi.org/10.1684/epd.2020.1189
Livvy Ashton

Livvy is a registered nurse (RN) and board-certified nurse midwife (CNM) in the state of New Jersey. After giving birth to her newborn daughter, Livvy stepped down from her full-time position at the Children’s Hospital of New Jersey. This gave her the opportunity to spend more time writing articles on all topics related to pregnancy and prenatal care.

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.

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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