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FDA approves first ever drug derived from marijuana

On June 25, the US Food and Drug Administration (FDA) approved the first drug based on compounds found in marijuana.

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

Now that Epidiolex is approved by the FDA, cannabidiol will probably be reclassified by the Drug Enforcement Administration within 90 days.

The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC).

Many families have moved to states where marijuana is legal medically or recreationally so they could treat their children with CBD on their own.

The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5. "And, the FDA is committed to this kind of careful scientific research and drug development", FDA Commissioner Scott Gottlieb, M.D, said. 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.

Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.

The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief.

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today.

"The DEA will not prevent Epidiolex from being sold", Fox said Monday.

"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.

"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.

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. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery".

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

The FDA's decision was expected. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

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