On April 7th, the U.S. Drug Enforcement Agency announced that it no longer considers Epidiolex a drug, a move that boosted its manufacturers stock price as soon as the news was made public. Created by GW Pharmaceuticals as a treatment for some of the most severe forms of epilepsy, this medication has been a lifesaver for many patients around the world.
Epidiolex is the only plant derived cannabis medication available on the market today and was considered a schedule V drug under the federal controlled substances act until this most recent ruling. Schedule V drugs are considered to have the lowest potential for abuse and addiction. Cannabis, however is still considered Schedule I by the Drug Enforcement Administration, which means it currently has no accepted medical value, high potential for abuse and In the same category as Heroin and LSD.
Here's what the FDA had to say about their decision to allow GW Pharmaceuticals to bring this important medication to market and its impact on their approach to CBD based products:
"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," - 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" - FDA Commissioner Scott Gottlieb, M.D.
Approved for use in June of 2018, Epidiolex is an oral solution that is used in the treatment of seizures associated with two of the most severe forms of epilepsy, Dravet Syndrome and Lennox-Gastaut Syndrome, in patients at least two years old.
Dravet Syndrome occurs within the first year of birth and causes frequent and prolonged seizures. Approximately 1 out of every 15,700 infants will be diagnosed with this rare form of epilepsy and 15-20% face the prospect of dying from SUDEP (Sudden Unexpected Death In Epilepsy).
As of today there is no cure and very few treatments available, which is what makes progress with Epidiolex so important. Being able to have better control over the frequent seizures not only makes a better quality of life for the patient but also vastly improves the life of their family.
Charlotte Figi, who recently passed away at the age of 13, was the first patient with Dravet Syndrome to successfully treat her seizures using CBD and was the inspiration for Charlotte's Web CBD. Charlotte is also credited with being a driving force behind the recent wave of cannabis legislation and legalization across the United States.
Lennox-Gastaut Syndrome occurs during infancy or early childhood, most often affecting children between the ages of 3 and 5. This is one of the rarest forms of epilepsy in the world, and presents itself in 2 out of every 100,000 children. While there is no set definition for diagnosing this illness in the medical community, there are generally 3 accepted criteria which include multiple generalized seizure types, a slow spike-and-wave pattern, and cognitive dysfunction.
Currently, there isn't one specific treatment that will work for everyone, and Lennox-Gastaut Syndrome is resistant to anti-seizure medication. The good news is Epidiolex has been shown to be effective in reducing the amount and severity of seizures in affected patients.
The facts are clear. Epidiolex has no business being restricted in any way and the FDA did the right thing in easing restrictions and opening up access to this quality of life improving medication. Hopefully, they will soon realize how ridiculous it is to consider cannabis as harmful as heroin and LSD and allow science to finally research all the different ways cannabis-derived medication can help improve the lives of patients across the globe.