US OKs marijuana-based prescription drug for seizures

Grant Boone
June 26, 2018

The drug, called Epidiolex, is an oral solution containing highly purified cannabidiol (CBD), which is one of scores of chemicals in the cannabis sativa plant, commonly known as marijuana. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.

"It has shown in placebo trials it can reduce seizures in certain types of childhood-onset epilepsy and we believe it would a breakthrough in the USA and hopefully in the United Kingdom next year". This drug does not contain THC, which is the part of the marijuana plant that would get someone high. In one study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median frequency of convulsive seizures to 5.9 a month from 12.4 before treatment, while patients getting a placebo saw minimal reductions, according to results published previous year in the New England Journal of Medicine.

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", Wirrell told the Associated Press.

Figi's daughter, Charlotte, was the first to use the Colorado CBD.

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.

"Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients", FDA Commissioner Scott Gottlieb, said in a statement today. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.

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Nine states and the District of Columbia have legalized marijuana for recreational use. This status has stifled rigorous research, because the federal government will not pay for it.

In the broader scheme, FDA approval of Epidiolex will likely lead to DEA declassification of CBD as an illegal Schedule I narcotic, which could ultimately open up opportunities for FDA approval of CBD for treatment of other ailments.

The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.

Epidiolex is manufactured by the British firm GW Pharmaceuticals, which funded the clinical trial.

A reclassification is expected within 90 days, according GW Pharmaceuticals. Previous year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

Commenting on the agency's decision, NORML Deputy Director Paul Armentano said: "The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis".

The European Medicines Agency is expected to rule on the therapy in early 2019.

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