U.S. FDA Approves Cannabis-Based Medicine

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

The U.S. Food and Drug Administration announced Monday, June 25, that it's approved a marijuana-derived drug for the first time.

Epidiolex is a twice-daily oral medication that can be usedfor patients two years of age and older, who suffer from two types of Epilepsy.

This bit of marijuana news marks the first time in the history of the USA that the FDA has given its approval to a purified drug derived from marijuana.

Epidiolex, made by British biopharma company GW Pharmaceuticals, uses purified cannabidiol (CBD), which is one of more than 80 active compounds in the cannabis plant.

Lennox-Gastaut syndrome and Dravet syndrome - conditions that both begin in childhood - cause frequent seizures and severely impact patients' quality of life. The company said it expects the DEA to act "within 90 days" and plans to roll out the drug this fall.

The GW Pharmaceuticals team said in a statement it was pleased to finally have such an important drug on the market to provide hope to two long and hard types of childhood-onset epilepsy. Although a synthetic version of THC, marijuana's main psychoactive ingredient, has been legally available as a treatment for nausea and appetite loss since 1985, this is the first time the federal government has given its blessing to a medication derived directly from cannabis. Though CBD doesn't induce the high associated with marijuana use-THC does that-it's now classified as Schedule I, a category that covers drugs with no therapeutic value and high probability of abuse.

A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.

Simeone says Argentina look lost, questions Messi in leaked audio
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In one clinical trial (published by The New England Journal of Medicine), Epidiolex reduced monthly drop seizures by 37.2 percent (10 mg/kg/day dose) and 41.9 percent (20 mg/kg/day), compared with a 17.2 percent reduction for placebo.

But Dr. Gottlieb also held out the possibility of more approvals for marijuana-based drugs down the road.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued.

There are side effects, the most common being sleepiness, Gover said.

He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.

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