In June 2018 the FDA approved a prescription drug called Epidiolex. If you haven’t heard the news yet, this is huge for the medical industry.
What’s so special about Epidiolex?
It’s the first FDA approved prescription drug made from cannabis. In the past, the FDA approved drugs with synthetic THC, but not derived from actual cannabis. Until now, cannabis products were listed as schedule l drugs under the Controlled Substance Act (CSA). Drugs listed under Schedule l are considered not acceptable for medical use and have a high potential for abuse. This puts drugs like heroin and LSD alongside cannabis. According to the CSA, Epidiolex is now listed under Schedule V. Drugs placed under Schedule V are accepted for medical use with a low chance of abuse.
What is it for?
Epidiolex is a cannabidiol (CBD) that is meant to help reduce two rare forms of epilepsy called Lennox-Gastaut syndrome and Dravet syndrome that begin in early childhood. Not only is treatment limited, it is also difficult.
In hopes of finally finding something to help their children, some parents are trying other alternatives, like CBD.
So far, the findings seem promising. A clinical trial published in the New England Journal of Medicine found the following:
- 43% of patients had at least a 50% reduction in convulsive seizures
- 5% of patients became seizure free
- Median frequency of seizures decreased from 12.4 to 5.9 (compared to the placebo which reduces seizures from 14.9 to 14.1)
Additional studies suggest Epidiolex, in combination with antiepileptic drug therapy, reduces the frequency of drop seizures in patients with treatment-resistant Lennox-Gastaut syndrome. Atonic Seizures, commonly referred to as drop seizures, occur when a person suddenly loses muscle tone which causes their head or body to go limp. This type of seizure are atypically brief and more common in children.
A recent study compared the efficiency of different dosages of Epidiolex in patients with Dravet Syndrome. This marks the second phase three trial that showed positive results. The trial consisted of 199 patients in a randomized, double-blind placebo controlled trial. After 14 weeks of treatment here are the findings:
- 46 percent of seizures reduced in patients taking 20mg a day.
- 49 percent of seizures reduced in patients that took 10mg.
- 27 percent of seizures reduced in patients placed in the placebo group.
It’s important to note that some participants experienced side effects. Common side effects include insomnia, decreased appetite and somnolence.
For a more information the potential side effects click here.
THC vs. CBD
Many people mistake THC and CBD as one in the same, but that’s not necessarily the case.
They both come from the cannabis plant, but THC is from marijuana while CBD comes from hemp. THC is the psychoactive ingredient in marijuana that makes users feel high. CBD, on the other hand, contains trace amounts of THC and aims to provide benefits without making you feel high whatsoever.
The Future of CBD
CBD’s legal status is a bit confusing, but hopefully that’s all about to change with the Farm Bill of 2018 which legalizes hemp. Trump signed the bill which legalized hemp and removes it as a schedule 1 drug according to the Drug Enforcement Agency under the Controlled Substance Act (CSA). This paves the road for more opportunities in terms of research on CBD’s role as a natural supplement.
For now these studies are promising, but the future of CBD is just beginning.