‘Epidiolex’ – world’s first medicine made from marijuana: All your questions answered

Created by GW Pharmaceuticals, Epidiolex is an oral solution of cannabidiol (OSC) and does not cause intoxication or a high.

By: Express Web Desk | Updated: June 28, 2018 12:04:44 pm

US health regulators approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use. (AP Photo)

In a landmark decision, the US Food and Drug Administration on June 25 approved the first medical drug made from marijuana. Created by GW Pharmaceuticals, Epidiolex is an oral solution of cannabidiol (OSC) and does not cause intoxication or a high. The drug will be used to cure severe forms of epilepsies in children. The New England Journal of Medicine had first provided the evidence that marijuana can cure epilepsy. “Today’s approval of Epidolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” said Justin Gover, GW’s Chief Executive Officer.

What is Epidolex?

Acording to GW Pharmaceuticals, Epidolex is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs). In a press release, the USFDA said, “CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).”

Why is Epidolex creating so much hype?

The Drug Enforcement Administration (DEA) continues to categorize marijuana as a Schedule I drug. The Schedule I drugs, substances, or chemicals are defined as ‘drugs with no currently accepted medical use and a high potential for abuse’. Now with FDA giving authentication to Epidolex which contains CBD, it is now creating headlines as it challenges that classification head on. On their website Greenwichbiosciences.com, the company said, “It could be a prescription medicine that would be treated like any other FDA-approved medications that have been tested and studied through the same rigorous process and manufactured through current Good Manufacturing Practice (cGMP).”

Does Epidolex have any side effects?

In its press release, the FDA said, “The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise and weakness, insomnia, sleep disorder and poor quality sleep, and infections.”

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