Today, the US health regulators announced the approval of Epidiolex — the first prescription drug made from marijuana. This marks a turning point in American federal law with relation to the substance which currently remains illegal (despite growing legality for recreational and medical use at State level). Across the US, cannabis legality varies state by state. Epidiolex marks the first acceptable cannabis medication approved by the Food and Drug Administration.
Epidiolex is used to treat two rare forms of epilepsy that presents itself in childhood. The strawberry-flavored syrup is a purified form of CBD which is extracted from the cannabis plant. CBD has been known to ease the symptoms of seizures, though the medical reasoning for this is still uncertain.
The medicine is essentially a pharmaceutical-grade version of CBD oil, which is already used by many parents to treat epilepsy in children. CBD derived from hemp seed is legal across the entire US and is bought widely to help stave off symptoms of various conditions. However, CBD is also one of the many chemicals found in marijuana and CBD from these sources has been illegal.
This is the exciting fact about Epidiolex; it is the first legal medical-grade CBD-based treatment which has come from marijuana.
It’s important to note that CBD doesn’t contain THC, which is the mind-altering chemical which delivers the “high” of consuming or smoking cannabis.
GW Pharmaceuticals (NASDAQ:GWPH)
England-based GW Pharmaceuticals studied the effects of Epidiolex in over 500 children and adults with hard-to-treat seizures. Results concluded that when combined with other epilepsy treatments, Epidiolex was effective at reducing seizures. The pharma company has pushed for legislation in several states so as to allow the legal selling and prescribing of their drug but the price of the drug has yet to be announced. Predictions from Wall Street analysts have it potentially listed at $25,000 per annum, though, this is speculation only at this early stage.
At such a high price, one wonders will the cost deter potential users away from it.
Physicians say it’s important to have a consistent, government-regulated version; Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy stated upon hearing the news:
“I’m really happy we have a product that will be much cleaner and one that I know what it is…In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”
Epidiolex is expected to launch in the fall.
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