Review Study Supports Ability of Epidiolex to Reduce Seizure Frequency in Dravet, Lennox-Gastaut Patients

Joana Carvalho avatar

by Joana Carvalho |

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Epidyolex UK

GW PharmaceuticalsEpidiolex, the first plant-derived cannabidiol medication to be approved by the U.S. Food and Drug Administration, is effective in significantly reducing the frequency of epileptic seizures as an adjunct therapy in children with Dravet syndrome and Lennox-Gastaut syndrome, a review study shows.

The review, “Epidiolex (Cannabidiol): A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes,” was published in Annals of Pharmacotherapy.

Dravet and Lennox-Gastaut syndromes are two rare medical conditions characterized by severe recurrent seizures that fail to respond to treatment with conventional anti-epileptic drugs.

“The frequency and severity of seizures have profound impacts on quality of life, risk for injury (eg, convulsive seizures in [Dravet syndrome], drop seizures in [Lennox-Gastaut syndrome]), health care use, and increased risk for mortality,” the researchers wrote.

Marketed by Greenwich Biosciences, a subsidiary company of GW Pharmaceuticals, Epidiolex is a purified liquid formulation of plant-derived cannabis that is supplied as a 100-mg/mL strawberry-flavored oral solution in a sesame oil base.

It is carbohydrate neutral and compatible with ketogenic diets — a diet high in fats and low in carbs that has been shown to reduce the frequency of seizures and improve cognitive function in children with Dravet syndrome.

Previous clinical trials have found that Epidiolex effectively reduces the frequency of epileptic seizures when used in combination with other anti-epileptic medications.

Researchers in this study reviewed the main findings of these trials regarding the safety, efficacy, and tolerability of Epidiolex for the treatment of children with Dravet and Lennox-Gastaut syndromes.

Relevant studies focused on assessing the efficacy and safety of Epidiolex in patients were identified through the EMBASE and Ovid MEDLINE databases. Studies on the pharmacokinetics — essentially how the body affects a medicine — in humans, animal models, and lab-cultured cells were also included in the review. Information on clinical trials was also extracted from

In total, three pivotal, multinational, double-blind, placebo-controlled, Phase 3 trials, all part of the GWPCARE series, were included in the review. All these trials were built on the foundation laid by a previous prospective, multicenter, open-label Expanded Access Program (EAP) trial designed to evaluate the effects of Epidiolex in a group of 162 patients with treatment-resistant epilepsy.

According to the researchers, the EAP trial was the first to present preliminary evidence suggesting “CBD’s positive effect in reducing seizure frequency and tolerable safety profile.”

In all three trials that followed — GWPCARE1 (NCT02091375), GWPCARE3 (NCT02224560) and GWPCARE4 (NCT02224690) — Epidiolex showed higher effectiveness in reducing the prevalence of seizures by 17-23% than a placebo, when administered in combination with conventional anti-epileptic drugs in children older than 2 years.

“These trials revealed CBD’s efficacy in reducing the frequency of the primary seizure type over a 14-week period compared with placebo, providing compelling evidence for the role of pure, plant-derived CBD in the management of DS and LGS,” the researchers said.

Common side effects associated with Epidiolex included somnolence, diarrhea, vomiting, decreased appetite/weight loss, and elevated hepatic transaminases (high levels of liver enzymes that might indicate liver damage).

Further chemical analysis also revealed that when used together with another anti-epileptic medication, such as Onfi (clobazam) or Depacon (valproate sodium), Epidiolex may increase the risk of side effects and should, therefore, be administered with caution.

“Although associated with adverse events, CBD is well tolerated and is considered to be a safe and reasonable treatment option for patients 2 years of age and older with DS and LGS,” the researchers said.

After being approved in the U.S. in June 2018, Epidiolex may continue its journey toward Europe soon, with the results from its marketing authorization application to the European Medicines Agency anticipated early this year.


Melinda Lopez avatar

Melinda Lopez

My name is Melinda Lopez and I live in Odessa, TX. I been having seizures for most of my life (28 years old). I been treated by the following drugs:
Keppra 750 mlg and Tegratol 200 mlg
But even do that I take them I still have the seizures.
Lately I went to see Dr. Omman in Lubbock, Texas and I was under surveillance in a hospital room for a week. The Doctor reduce my doses of Keppra to 500 and the Tegratol to find out that if I have the seizures during the night while i sleep. Turn out that I have none during the night and ended having 4 during the day.
Doctor Omman concluded that in order to fix my problem need to place a brain pacemaker on my chest.
I would like to find out if this Epidiolex can help me, because I really don't want the brain pacemaker.
I would appreciate any help or advice.
Thanks in advance for your time.

Pedro Navarro Cruz avatar

Pedro Navarro Cruz

Hey Melinda,

My 5 year old started using Epidiolex about 3 months ago and his seizures significantly decreased. He went from having several seizures a week to only 2 that we know of in the last 30 days.

He also takes 100 mg/ml 4 ml twice a day of Keppra and 375 mg of Divalproex twice a day.

We recommend it. Ask your doctor about it.

Good luck

Monica avatar


Hi Melinda, did you try Epidiolex? My daughter is on the same medicines and not helping neither. Pls let me know if it help you. Thanks

Kawanda Frazier avatar

Kawanda Frazier

Hello my son is 25 and has had seizures since 1 month old and has had every medication for seizures out and available he does have the vns magnet which u reference it being the pacemaker it has worked wonders! He’s now trying the CBC to try and get off his other medications and at first it was great and three months in he is having major side effects and quality of life has gone down I would not recommend it the magnate is so much better without it effecting ur life as much

Lynne Rakowitz avatar

Lynne Rakowitz

Looking for an adult that is on Epidiolex, to get information about your experience

Aracely Zambrano avatar

Aracely Zambrano

My daughter is 23 years old with Intractable Epilepsy since she was 11. She had a brain surgery with no success of being seizure free at the age of 16. She had a VNS implanted a year after that and helps maybe 10% of the time she is currently taking Epidiolex for the past 3 months and prior that on Charlotte’s Web for 3 years. Those two have given her a better quality of life from 20-30 seizures a day she has 2-3 a day now and sometimes 0 a day thanks to the Epidiolex medicine. Doctor is currently trying to take her off Lamotrigine because of lowering of White Blood Cells and she also takes Primidone and Onfi at this time. She has tried all the epileptic medications basically out there but nothing has helped like Epidiolex and the Charlottes Web she use to take in the past. I call it her Miracle Medicine

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