FDA Approves CBD-Based Drug For the First Time: What’s Next?

FDA Approves CBD-Based Drug For the First Time: What’s Next?

The FDA approves CBD or, to be more precise, the first CBD-based drug, Epidiolex. Can it help reschedule cannabis?

Whether you use hemp CBD oil to improve the quality of your life, or you live in a state with lenient laws on cannabis, you are probably well aware of the health benefits of the plant. Plus, if you’ve been watching the latest steps undertaken by the Food and Drug Administration (FDA), you know that they have been hinting about cannabis reform for well over a year now.

But what the FDA did on June 25, 2018 was groundbreaking. The FDA issued a press release in which it approved the first cannabis-derived drug for the treatment of two rare and severe forms of epilepsy. Simply put, for the first time in history, it’s now federally legal to take a CBD-infused drug Epidiolex.

What is Epidiolex?

So, what’s the deal with the fact that the FDA approves CBD? Does it treat all CBD-based products like drugs now?

No, absolutely not.

The FDA’s approval applies only to Epidiolex, a drug directly sourced from cannabis, developed by the British company GW Pharmaceuticals.

The main active ingredient in Epidiolex, an epilepsy drug, is CBD, short for Cannabidiol. Epidiolex is an isolated form of CBD and contains less than 0.1% THC, the intoxicating compound in cannabis, which makes it federally acceptable.

Will FDA approve CBD In Its Full Spectrum?

It looks like we can be optimistic about it in the near future. Epidiolex received the approval during an FDA advisory panel in April, 2017, specifically for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two rare and severe forms of epilepsy that show up at an early age.

It took the FDA one year to ultimately approve the Epidiolex therapy for both conditions in children 2 years of age and up. The FDA made this decision on 25th June, 2018. GW Pharmaceuticals, a large pharmaceutical company achieved it through careful, well-designed clinical trials.

In fact, they only proved what many CBD users believed was true long time ago. But then again, the FDA has finally managed to officialy acknowledge one of the two predominant compounds in the cannabis plant as having medical benefits.

The Contradiction Between FDA and DEA

While the FDA approves CBD for the first time in history, the Drug Enforcement Agency (DEA) still considers cannabis and its compounds dangerous, including both THC and CBD. The agency classifies them as “Schedule I drugs with no currently accepted medical use and high potential for abuse.” As you can see, this classification is contradictory to what the FDA said in their press release a couple of weeks ago.

On the one hand, the FDA approves CBD or, to be more specific, a CBD-based durg, Epidiolex, for medical therapy. On the other hand, the DEA considers marijuana and its derivatives to have no medicinal value. Federal opinion on cannabis is even more confusing when you take into account the fact that the U.S. Department of Health and Human Services holds a patent on “Cannabinoids as antioxidants and neuroprotectants” since 1998. The number of the patent is 6630507.

Finally, there is the Farm Bill of 2014 that made hemp and hemp-derived products legal on the federal level and granted the states the right to cultivate and research hemp for industrial and academic purposes. Yet, the FDA does not acknowledge the hemp-derived CBD as a medicine. They classify CBD oil as an over-the-counter supplement that has no proven medicinal value.

As you can see, the cycle of absurd continues.

Will the DEA Reschedule CBD?

It’s a natural question considering that the FDA approves CBD. Sadly, while the most renowned medical research centers around the world have been systematically compiling data on the medical qualities of cannabis, the DEA has refused to reconsider their outdated pattern of thinking. As for now, CBD remains a Schedule I substance despite the lack of intoxicating properties and serious side effects.

Surprisingly, even opioid-based drugs like Fentanyl and OxyContin have been classified as Schedule II drugs, meaning they have proven medical benefits despite their high potential for abuse.

If you’ve ever experienced CBD, be it from hemp or marijuana, you will note that there is a huge difference between the risk of cannabis consumption and the risks of opioid consumption. Moreover, when you consider the well-known safety of CBD, you simply can’t compare these two substances, yet the safer one still is Schedule I.

The Rescheduling of CBD Is Closer Than You Think

Well, it goes without saying that there is no rational reason why Cannabidiol is still classified as dangerous, outside money interests, of course. Now that the FDA approves CBD, legal experts predict that a rescheduling of cannabis, or at the very least Cannabidiol, is only a matter of time.

However, to move forward with this historic action, the FDA CBD committee must conclude  cooperation with the Justice Department.

As long as the current Attorney General, Jeff Sessions, remains in charge, the FDA might have a hard time changing the current tides. After all, Sessions is known for his backwards attitude towards cannabis, claiming that only “evil people” use the plant.

Hopefully, thanks to GW Pharmaceuticals – the company behind the extensive trials required for all drugs to be approved by the FDA – more research on Cannabidiol will emerge. A proven range of Epidiolex’s medical benefits with low risk for abuse means that CBD should fall under Schedule IV classification, or at least Schedule III.

Where’s the Catch With Epidiolex?

As much as we appreciate the progress that the FDA made by having accepted the first CBD-based drug for epilepsy, we do not share the same enthusiasm when it comes to the side effects o the drug. Here at CBD sky, we believe in the broad array of health benefits of full-spectrum Cannabidiol extracts. And while we agree that CBD is safe and doesn’t come with serious negatives, we have doubts about the safety of Epidiolex, though.

Here’s the list of potential side effects of Epidiolex:

  • drowsiness,
  • decreased appetite,
  • diarrhea,
  • transaminase elevations,
  • fatigue,
  • feeling unwell (malaise),
  • weakness/lethargy,
  • rash

As far as we’re concrened, only the first two side effects are attributed to Cannabidiol. Thus, the remaining symptoms are strange, to say the least. Nonetheless, we believe that these side effects are largely dosage-dependent.

The FDA Approves CBD: What’s Next?

According to the recent press release about the FDA’s approval of cannabidiol, CBD has been given the green light in the treatment of two rare and serious forms of epilepsy. These are: Lennox-Gastaut syndrome and Dravet Syndrome.

In both cases of childhood epilepsy, the Phase III clinical trials of Epidiolex “significantly reduced monthly drop seizure frequency compared to placebo in highly treatment resistant patients when added to existing treatment”.

Again, this study only proves what many parents have already known. However, now they can officially have access to an FDA-approved drug. Will the parents of epileptic children turn to Epidiolex as a relatively safe alternative to the standard pharmaceutical treatment?

It depends on the state they live in. Parents who live in marijuana-friendly states have long been treating their epileptic children with marijuana-derived oil. However, in order to give CBD oil to a child legally, parents must apply to a state’s medical marijuana program. Fortunately, severe types of epilepsy are accepted in the majority of medical states.

But what about those who live in states that don’t have a medical marijuana program yet? In this case, Epidiolex can prove invaluable. It is now their only legal way to use Cannabidiol. Those who don’t want to use pharmaceutical drugs, though, will seek relief in the hemp-derived cannabidiol.. FDA hasn’t approved the hemp-derived CBD as a drug yet – with “yet” being the key word here.

A Final Word on the FDA Accepting the First CBD-Based Drug

The fact that the FDA approved the first CBD-Based drug on 25th June, 2018, means that the organization became aware of the health benefits of Cannabidiol. This is a huge step forward if you ask us. While it may take some time until all forms of CBD become approved by the FDA, we can soon expect the reclassification of cannabis, or at least CBD, to a Schedule III substance.

Let’s keep our fingers crossed for that. Still, if you’re interested in buying the full-spectrum Cannabidiol extract, browse the selection of our CBD oil products. We source our cannabidiol from the finest, organic hemp, using the supercritical CO2 extraction method to ensure the ultimate potency and purity of the final product. Our CBD oil is 3rd-party lab tested for its cannabinoid content and the presence of contaminants, such as heavy metals, toxins, pesticides, and more.

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