US approves first cannabis drug against epilepsy

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Competent entities in the field of health approved the first prescription drug made from cannabis, a fact that could lead to more research of a medicinal plant that, despite its regulation in some parts of the world, remains illegal at the federal level in the United States.

Epidiolex, is the medicine prepared by the British pharmaceutical GW Pharmaceuticals, received the endorsement of the Food and Drug Administration (FDA) for showing effectiveness in the treatment of two rare types of epilepsy.

This drug is not exactly medicinal cannabis flowers, but pharmaceutical grade cannabidiol oil (CBD). CBD is a non-psychoactive cannabinoid -one of the more than 100 components found in the plant- that has been shown to be effective against a variety of conditions, including epilepsy.


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FDA officials told AFP that this is an effective medication when combined with other types of drugs for epilepsy. Currently, a lot of parents treat their children with CBD extracts and oils.

A legal issue has allowed the production of CBD products, however, many of them are extracted from hemp, a variety of cannabis, which show lower yield than products made from specialized CBD genetics with higher amounts of cannabinoids.

The FDA has issued statements about products claiming to treat diseases, but they are only dietary supplements rich in Omega 3,6 and 9, and not necessarily therapeutic.

The Epidiolex brings something that doctors are waiting for: consistency. The rigorous clinical trials for distribution and manufacturing could be attractive to parents of families struggling to obtain the same products and for the medical profession.

GW Pharmaceuticals has studied the behavior of this drug in more than 500 children with cases of epilepsy undergoing the harsh controls imposed by the FDA to study the components of cannabis.

Specifically, the drug approved by the FDA is limited to the treatment of Dravet Syndrome and Lennox-Gastaut, two rare manifestations of epilepsy for which there are no effective medications. But doctors may have the possibility of prescribing in various conditions.

The company has not yet formalized the cost of the treatment and is expected to be in the fall. It is estimated that it could have a cost per patient of $ 25,000 per year, according to Wall Street analysis.

It is estimated that in the United States, families invest up to $ 1,800 per year in CBD products.

The impact this has for the industry and federal regulation is still uncertain.


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Posted by Medical Cannabis News – MCN on Wednesday, September 27, 2017

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