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First Cannabis-Based Drug For Childhood Epilepsy Approved in USA

First Cannabis-Based Drug For Childhood Epilepsy Approved in USA

The US Food & Drug Administration has approved Epidiolex, which is expected to be available by autumn

Mike Wood

Mike Wood

American authorities are on the brink of legalising the first cannabis-based medical treatment after the US Food and Drug Administration (FDA) approved a drug that is used to treat epilepsy.

Epidiolex is a strawberry syrup that has been infused with CBD, one of the active ingredients in marijuana, and can be used as a treatment for several forms of epilepsy.

It does not qualify as medical marijuana as CBD is the relaxant chemical compound in cannabis, as opposed to THC, the element of the drugs that induces the feeling of being high.

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CBD is effective in treating two different types of epilepsy, LGS and Dravet Syndrome, which can cause seizures and other symptoms.

"Today, the FDA approved a purified form of the drug cannabidiol (CBD)," wrote FDA Commissioner Dr. Scott Gottlieb in a statement on their website.

"This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older.

"This approval serves as a reminder that advancing sound development programmes that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.

"And the FDA is committed to this kind of careful scientific research and drug development."

Epidiolex is made from purified CBD and developed by GW Pharmaceuticals, a UK-based company that has grown cannabis legally under licence from the UK Home Office in order to carry out research.

50 children in the UK have been given Epidiolex as a treatment as part of a large scale clinical trial that took in 1,500 kids worldwide.

The decision was hailed as 'a historic milestone' by Justin Gover, CEO of GW Pharmaceuticals. He described it as the 'first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies.'

He added: "These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care."

Now that FDA approval has been granted, the producers of the drug now expect for it to be available by the autumn.

The cost of the drug is yet to be revealed, with discussions due to take place between manufacturers such as GW Pharmaceuticals and health insurance providers in the United States.

The European Medical Society is also mulling over the approval of the drug, which could see it used on this side of the Atlantic sooner rather than later.

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Topics: US News, Cannabis, Marijuana, weed