For first time ever, FDA approves marijuana-derived medicine

Regulators at the US Food and Drug Administration today granted market approval for Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

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

"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands. MOst CBD comes from hemp, and for any plant to be considered "hemp" it must contain less than 0.03 percent THC. The medication has been approved for patients aged two years or older and marks the first time the agency has approved a drug derived from cannabis.

An advisory panel to the FDA recommended in April that the drug be approved. 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.

He says the reclassification is underway now.

A flowering marijuana plant is pictured at the Canopy Growth Corporation facility in Smiths Falls, Ontario, Canada, January 4, 2018.

Dr. Anup Patel, neurology section chief at Nationwide Children's Hospital in Columbus, said Monday's announcement is good news for epilepsy patients who have been waiting for relief from the state's 2016 medical marijuana law or have been experimenting with unregulated products claiming to contain CBD.

Several states have legalized CBD oil specifically for the treatment of intractable epilepsy or seizure disorders.

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And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said. "If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis".

"In the world of Dravet, there is always the fear of "running out of options" and now, as a community, we have one more option which gives families more hope and peace of mind", she added.

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said.

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

The company has not said how much the drug will cost, but Wall Street analysts have predicted it could cost $25,000 per year.

Across the board, the drug was shown to be effective in cutting the frequency of seizures.

The FDA's decision is historic but it is not unexpected.

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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