Could this be a pivotal turning point for marijuana as a medicine in the United States?
The solution received approval from the U.S Food and Drug Administration back in June but it was only more recently, on Thursday, November 2, that Epidiolex became available throughout the 50 states.
Epidiolex is the first-ever FDA approved drug that is derived directly from species of the cannabis plant. This comes despite the fact that the FDA has not legalized or approved cannabis as a medicinal nor a recreational plant.
Could this New Approval for Epidiolex Change Things?
Despite several states have already legalized the recreational or medicinal (or both) use of marijuana, the plant is still listed as a schedule 1 substance.
What does the Schedule 1 Substance Categorization Mean?
For a plant, substance or drug to be listed as a schedule 1 substance, it means that the substance has a high potential for abuse and it also cannot have any recognized medicinal use or potential.
Some of the other substances on the schedule 1 list include:
For this reason, it seemed imminent that the FDA would need to reschedule cannabis, or at least clarify the scheduling of the active compounds used for the FDA approved Epidolex.
This is why the DEA, along with the FDA’s approval, announced the rescheduling of CBD drugs. This rescheduling is only permissible for “approved FDA drugs” and is not a broad ‘umbrella’ classification for all CBD products, or for the cannabinoid itself.
According to the DEA, the defined approval for CBD substances, drugs or medicines is the following:
“Approved cannabidiol drugs. A drug product in finished dosage formulation that has been approved by the U.S Food and Drug Administration that contains cannabidiol (CBD)…derived from cannabis and no more than 0.1 % residual THC.”
This means that there are the following criteria for a product to meet before it can be labeled as an approved CBD product or drug:
- It must have FDA approval
- It must be derived from cannabis
- It must contain less than 0.1% THC
Epidiolex is the first and so far the only product that has attained this approval. Epidiolex made a landmark as being the first approved cannabis-derived drug to be available (by prescription only) in all 50 states across America.
Are CBD Oils, Tinctures, Edibles and/or Topicals also Approved?
No, they are not. While the sale and use of these products may be legal according to some state laws, they do not have FDA approval and, as such, are not approved CBD drugs. Although some of these products may contain less than 0.1% THC, they do not have FDA approval. These products are, in the legal states, allowed to be sold through licensed dispensaries and obtained through licensed producers and manufacture.
Epidiolex is an oral solution that can be obtained through a prescription. It is recommended to take the oral solution twice a day and it is not permitted for those under the age of 2 years. It is specifically prescribed in order to treat the following:
- A rare and severe form of epilepsy, Dravet’s Syndrome.
- A severe form of epilepsy, Lennox-Gastaut Syndrome.
Both of these forms of epilepsy begin in the early stages of childhood.
Dravet’s Syndrome develops in the child’s first year of age and is classified as being a genetic dysfunction of the brain.
Lennox-Gastaut Syndrome is a severe form of epilepsy that can manifest in a children between the ages of 3 – 5 years of age. Lennox-Gastaut is a type of epilepsy where the child experiences multiple types of seizures.
Previously, children diagnosed with these syndromes did not exhibit positive responses to medication. Available seizure drugs did not prove to be effective and thus there is a need for treatment options that are effective and potentially life-saving.
Justin Gover, CEO of GW Pharmaceuticals (the developers behind Epidolex), says that their company sought to use cannabis as a means to address this dire need. In a written statement, the CEO states that the company sought to meet the need for new therapies that aim to treat the frequency and severity of these seizures in young children.
He goes on to say, “ We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”
In June 2018, GW’s drug Epidiolex was submitted for approval and received said approval two short months later, in June. However, clarification was needed on the DEA’s classification of the drug- no FDA approved drug could be classified as a schedule 1 drug, since schedule 1 substances cannot, by definition, have any accepted health benefits. Therefore, in September 2018, Epidiolex was rescheduled to category V by the US Dep. Of Justice, as well as the DEA. This was the final obstacle which allowed Epidiolex to be prescribed by doctors across the country.
However, both cannabinoids CBD and THC remain under Schedule 1 classification.
Clinical Studies for Epidiolex and Epilepsy
According to a written statement released by the FDA commissioner, Dr. Scott Gottlieb, “Adequate and well-controlled clinical studies supported Epidiolex’s approval, so 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.”
The statement went on to say that, “The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high-quality products.”
The lead investigator for two of Epidolex’a clinical trials was the Director of the Comprehensive Epilepsy Center at NYU Langone Health, Dr. Orrin Devinsky. Epidiolex underwent three different three-phase clinical trials. According to Dr. Devinsky, Epidiolex exhibited the following results during the clinical trials where he was lead investigator:
- In the cases where Epidiolex was used in addition to other medications, the average result was that the frequency of convulsive seizures was reduced by between 25% and 28%.
- Epidiolex is clearly effective as well as showing results in all three studies.
- However, the effect, although noteworthy, was modest.
Dr. Devinsky went on to say that the results were mixed; with some patients experiencing a large improvement, others a more modest improvement and still others who did not experience any improved at all. The doctor went on to stress the importance of not labeling Epidiolex as a ‘miracle’ drug or cure, even if it does have good effects in comparison to other epilepsy medications.
Side Effects of Epidolex
According to GW Pharmaceuticals, the most frequently experienced side effects include the following:
- Decreased appetite
- Increase in the number of liver enzymes
Validation of Cannabinoids as Medicine
Despite the cannabinoids (CBD and THC in particular) still being classified as a schedule 1 drug, the approval of Epidiolex validates the science of cannabinoids being used as medicine. While the evidence for using cannabis as medicine is somewhat mixed, the approval of FDA approval of Epidiolex does highlight that there is justification for the many anecdotal reports for those that swear by the effectiveness of cannabis, and the cannabinoids therein, as medicine.
Full spectrum CBD vs. Epidolex
What is begging to be asked is this; would Epidiolex be more effective if it contained the full spectrum of cannabinoids?
One of the primary questions circulating the cannabis industry is what is the most effective way to use cannabis? This question almost always brings the consumer to the ‘Entourage Effect’ and ‘cannabis synergy’. The ‘entourage effect’ concept was first published in 1999 by researchers Raphael Mechoulam and Shimon Ben-Shabat. While researchers have found approximately 66 cannabinoids and more than 400 chemicals in cannabis, research is suggesting that the full effectiveness of cannabis is found when all of these compounds are working together synergistically.
So then, what are the differences between Epidiolex and Full-Spectrum CBD?
While Epidiolex may be derived from cannabis, it is different from full-spectrum CBD. Because of the above mentioned synergistic effects, the two interact rather differently with the endocannabinoid system. It is the same as the difference between eating an orange for Vit. C and simply taking a Vit. C supplement and it all comes down to:
These are compounds that are the root cause of a plant’s smell and color. However, the role of phytonutrients does not simply end there. These compounds that create a plant’s color and smell are nutrients that assist with the absorbing and assimilation of the key nutrient, in this case; CBD. They also contain antioxidants as well as other nutritional health benefits.
How to Understand Full Spectrum CBD (and why you should care)
Full spectrum CBD contains all the naturally occurring cannabinoids, compounds, and phytonutrients that work synergistically, and this is what is what causes the increase of efficiency and effectiveness. While there are many cannabinoids within the cannabis plant, each of these cannabinoids is unique and play a specific role within the endocannabinoid system.
Once the CBD cannabinoid is extracted (as in the case of Epidolex), it becomes labeled as a ‘CBD Isolate’.
Once the CBD is isolated, there are no more terpenes, flavonoids, cannabinoids or phytonutrients to assist. This is why some researchers argue that CBD Isolate is not as effective as Full Spectrum CBD.
In 2015, The Hebrew University of Jerusalem’s Lautenberg Center for General and Tumor Immunology conducted a study and identified this ‘Entourage Effect.’ According to the study, full spectrum CBD is far more effective than CBD isolate. This concept is what is known as the ‘Entourage Effect’.
While the FDA approval of Epidiolex is a positive step in the right direction, there still needs to be more research into how cannabis can be safely and effectively used as a full spectrum medicine.
November 1st was the landmark day where Epidolex- North America’s first cannabis-based medicine- was able to be prescribed by doctors across all 50 states.