FDA approves first marijuana-derived drug- and it may spark DEA rescheduling

Epidiolex a medicine made from the marijuana plant but without THC

Epidiolex a medicine made from the marijuana plant but without THC

On Monday (June 25), the U.S. Food and Drug Administration announced their decision to approve the country's first cannabis-derived drug.

A new drug derived from marijuana just became the first of its kind to get the green light from the U.S. government.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it.

GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.

The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant - but not the one that gets users high.

"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products", said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research.

"This is an important medical advance", FDA Commissioner Dr. Scott Gottlieb said in a statement Monday. 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 a year ago in the New England Journal of Medicine. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research. 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.

Cannabidiol is derived from the cannabis plant, also known as marijuana. Epidiolex's approval also marks the first time the FDA has approved a drug to treat Dravet syndrome. Last year, one of GW Pharmaceuticals' affiliated companies, Greenwich Biosciences, began a lobbying campaign to change that.

In April, an advisory committee unanimously recommended approval of the drug for the two types of epilepsy. "Epidiolex has been studied and proven to significantly reduce seizures so, in a few short months, it will be a new and welcome product for doctors to consider for their patients in need".

Epidiolex will become available in the fall, Gover told CNN. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.

Carson says he will likely prescribe Epidiolex going forward.

Another 20 states allow medical marijuana, but the USA government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", said the FDA.

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.

Recommended News

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.