CBD Drug Receives EMA Marketing Approval

August 15, 2019 15:00:20

A CBD-based drug, Epidiolex, has received the nod from the European Medicines Agency (EMA) to start being marketed as an additional treatment alternative for two kinds of seizures. This recommendation will now be presented to the European Commission for a final vote before the drug can access the EU market.

It is almost certain that the EU Commission will approve the drug since the commission normally endorses the recommendations made by the human medicines committee of the European Medicines Agency.

The EMA based on the results of four randomized tests that the manufacturer of the drug conducted to show that the CBD-based medicine is safe and can treat the forms of seizures that it is intended to be marketed for.

It should be remembered that last year, Epidiolex made history as the first marijuana-based drug to be approved by the U.S. Food and Drug Administration (FDA) to treat two rare types of epilepsy that affect kids.

The approval by the FDA came along with a green light from the Drug Enforcement Administration (DEA) which categorized the drug as having a minimal potential to be abused.

Epidiolex is made from CBD, one of the hundreds of cannabinoids found in the cannabis plant. The drug has a THC content that is less than 0.1 percent, which is way below the U.S. legal definition of the THC content of industrial hemp that became federally legal with the passing of the 2018 Farm Bill.

If this drug finally makes its way onto the European market, it will create a ripple effect in even unexpected places.

For example, the U.S. federal government retains marijuana on Schedule I of the Controlled Substances Act, insisting that marijuana has a high potential for abuse and it has no known medical value.

If the FDA and the EU accept that a drug has been made from marijuana, doesn’t that bring into question the international classification of marijuana as a substance with no medicinal value?

From last year, the marijuana community has been waiting on a commission of the UN to pronounce itself on the recommendations that were made by a World Health Organization panel of experts to the effect that the classification of marijuana should be reviewed. However, the narcotics commission of the UN has kept postponing when the matter will be included on the agenda of their meetings.

In the meantime, evidence of the different therapeutic benefits of cannabis and its compounds is mounting, and this could explain why several countries and jurisdictions are defying the UN by legalizing marijuana either for recreational or medical use (or both).

CBD industry experts believe that industry players like Hemptown USA and IONIC Brands Corp. (CSE: IONC) (OTC: IONKF) will hope that the approval of Epidiolex to enter the EU market will result in more acceptance of CBD as a therapeutic cannabis compound.

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