FDA Approves Marketing Of Plant-Derived Marijuana Medicine

Epidiolex a medicine made from the marijuana plant but without THC

The Food and Drug Administration approved the medication, called Epidiolex, to treat two rare forms of epilepsy in patients 2 years and older.

A new drug derived from marijuana just became the first of its kind to get the green light from the USA government. But federal regulations classify CBD as a Schedule 1 drug, similar to heroin and cocaine, because it is a chemical component of the cannabis plant.

The FDA still hasn't given its blanket approval to marijuana as a "safe and effective drug", though it has OK'd three medications that contain synthetic compounds similar to those found in the marijuana plant.

Despite today's approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims".

"The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels", FDA Commissioner Scott Gottlieb said in a Monday press release. 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. The CBD oil derived from the marijuana plant has been administered to relieve insomnia, anxiety and chronic pain, as well as to treat multiple sclerosis and Parkinson's disease, among conditions, wrote Harvard Medical School professor Dr. Peter Grinspoon.

Marissa Parsons, who has Lennox-Gastaut syndrome, visits the Grand Canyon with her family in 2016.

Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse.

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A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall.

Even though 16 percent of trial participants experienced unwelcome side effects, such as diarrhea, vomiting and abnormal liver function, FDA officials and an advisory panel unanimously recommended its approval.

Medical marijuana is available in about half of the states.

In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for. The agency is expected to do so within 90 days. "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".

The drug should provide a more reliable alternative than the homemade cannabis oil parents for years have made for the children, said Devinsky, who once treated Vivian Wilson of Scotch Plains, a toddler with Dravet syndrome.

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.

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