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Epidiolex: GW Pharmaceuticals First-Ever FDA Approved CBD (Cannbidiol) Drug

David Renfrew

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Last year, the FDA approved a drug containing a key ingredient of marijuana for the treatment of certain rare and severe forms of epilepsy. The name of this drug is Epidiolex.

For anyone that has experienced seizures related to epilepsy, they know how bad it can be. It can take a toll on not just the patient themselves, but their parents, siblings, relatives and friends.

Thanks to Epidiolex though, these seizure episodes in people with certain forms of epilepsy are a thing of the past.

What is Epidiolex

This is currently the only FDA approved CBD based drug manufactured by GW Pharmaceuticals. It’s a 100 percent cannabidiol medication meant for patients with specific forms of epilepsy.

These rare forms include Dravet Syndrome, Tuberous Sclerosis Complex (TSC) and Lennox-Gastaut Syndrome (LGS). The drug proved specifically effective at curbing seizures in patients with these conditions. In fact, it’s the first FDA approved drug for Dravet Syndrome.

It is an oral medication manufactured from a highly purified plant-derived cannabidiol. It’s specifically effective for adult patients older than 2 years old. So, as long as they have these conditions, they can try Epidiolex for relief from seizures.

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The drug underwent various clinical trials before it was officially approved for the treatment of those conditions. There were three of the clinical trials. They were randomized, doubled-blinded placebo-controlled clinical trials involving over 516 patients suffering from either Dravet or Lennox-Gastaut syndrome.

Do You Need a Prescription for Epidiolex?

Right now, it’s a controlled substance under Schedule V of the Controlled Substances Act (CSA). What this means is that you cannot just find them in pharmacies and drugstores. And they’re not OTC meds either.

You need a specific prescription, and even then, you can only get it from designated pharmacies in the country. So, if you or a relative has any of these conditions, talk to your doctors about it.

The drugs have been proven to be highly effective against these conditions. Not only will it provide the relief from seizures or drastically reduce it, it’ll tremendously improve the quality of your life and that of those close to you.

Is Epidiolex CBD

Yes, it is. In fact, it’s a highly pure form of the cannabinoid called cannabidiol. And since it contains no THC, users never have to worry about getting high or suffering from any psychoactive effects. This is also why children above the age of 2 can take it. And if you’re wondering about children younger than 2 taking it, well, there’s no study or research to ascertain that. All the clinical trials carried out on the drug were focused on older children and adults suffering from the conditions.

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What Ingredients are in Epidiolex

Epidiolex consists primarily of 100mg/ml pure cannabidiol (CBD). This is the only active ingredient in the drug. Other inactive ingredients include strawberry flavor, sesame seed oil, sucralose, and dehydrated alcohol. So, unless you or your loved ones are allergic to any of these, taking the drug should be fine.

Epidiolex Cost

Epidiolex currently costs $32,500 per year. You can see the payment breakdown here in: payment breakdown pdf.

Yes, the payment for the medication is annual, and can be hard for some people to pay. There are questions about whether Epidiolex is covered by health insurance, but that’s not yet known.

But, Epidiolex.com shows that there’s the copay option, as well as a copay savings program that will help you save up to $2,600 a year. There’s also a Patient Assistance Program for eligible individuals who can’t afford the medication and have no insurance coverage.

So, it’s possible that your health insurance provider might require some out of pocket costs. Bottom line, you’ll have to talk to your insurance provider about this.

Are There Any Side Effects?

Yes, there are. Participants in the clinical trials reported side effects such as lethargy, sleepiness, decreased appetite, sedative effects, diarrhea, insomnia, rash, dark urine, elevated liver enzymes, jaundice, malaise and weakness, infections, abdominal pains, nausea and vomiting, sleep disorder and fatigue.

This is why the drug needs to be administered under the supervision of a medical doctor. Also, people who are allergic to cannabidiol shouldn’t take Epidiolex. As for those whose sole side effect is sleepiness, it’s possible that they’ll get better with time, and the side effects will wear off.

David Renfrew is just now beginning his journey at TOC but has found himself on the forefront of the Canadian cannabis culture and marijuana movement. Among being a vocal CBD advocate, Dave is also a politically active father, author, small business owner and fierce reader of fiction and non-fiction. While early, the strong research skills and truly gifted writing talent make David one of our top editors.

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