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FDA approves country's first medicine made from marijuana
The Food and Drug Administration on Monday approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.
The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," FDA Commissioner Scott Gottlieb said in a statement. "And, the FDA is committed to this kind of careful scientific research and drug development."
The FDA's decision was expected. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light. 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.
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. The agency is expected to do so within 90 days.
Cannabidiol (CBD).
Also at TechCrunch.
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World Health Organization Clashes With DEA on CBD; CBD May be an Effective Treatment for Psychosis
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(Score: 1) by khallow on Tuesday June 26 2018, @04:09PM (8 children)
(Score: 4, Insightful) by frojack on Tuesday June 26 2018, @04:24PM (3 children)
With the number of states legalizing Marijuana (recreational or medical) approaching a majority, soon a simple up or down vote is probably all that is needed to remove it entirely from DEA's mandate. None of the horror stories have come true. Even in the road crashes cases where marijuana was claimed a large percentage of had other alcohol involved.
Canada is lighting up this month.
Junk science takes way too long to be exposed.
No, you are mistaken. I've always had this sig.
(Score: 5, Insightful) by Thexalon on Tuesday June 26 2018, @04:54PM
Especially when there's so much money to be made from it not being exposed.
The only thing that stops a bad guy with a compiler is a good guy with a compiler.
(Score: 2, Funny) by realDonaldTrump on Tuesday June 26 2018, @06:33PM (1 child)
Let me tell you, there's no vote. There's a guy that decides. I pick that guy -- could be a lady -- and the Senate gives an OK. Or maybe the Senate is very foolish and they tell me, pick another guy. I haven't picked my permanent permanent guy for DEA. But I have Robert W. Patterson as the acting guy.
(Score: 1) by realDonaldTrump on Tuesday June 26 2018, @07:17PM
Looks like someone thinks just about every recent tweet I have made is a troll.
I think that someone lost very badly when we did have a vote -- when our great Electoral College voted in 2016 -- and now she hates our Country. She hates our terrific government. She lost to me. But she would have lost to Lyin' Ted. To Kasich. To Carson. And possibly even to Low Energy Jeb!
(Score: 2) by Runaway1956 on Tuesday June 26 2018, @04:37PM
Came to say very much the same. This would be awesome, if it were 1918. Now, in 2018, it's more like, "About frigging time!"
(Score: 3, Informative) by ilPapa on Tuesday June 26 2018, @06:52PM
Yeah, just legalize it. I live in a state where it's legal to grow, sell, possess and smoke pot, and you don't have to go through the dramatics of getting a doctor's note. Hell, in my town, you can have it delivered. And guess what? the world did not end. There are not crazed dope fiends running wild through the streets and children aren't being exposed to weed any more than they were previously.
I'm not a smoker, but it's pretty ridiculous that there are states that haven't done this yet. Legal weed is creating jobs, businesses, tax revenue, and people who aren't quite so stressed. I'm all for it.
You are still welcome on my lawn.
(Score: 2) by krishnoid on Wednesday June 27 2018, @07:37AM (1 child)
So there's no similar pharmaceutical from other countries with saner drug (and socialized medicine) policies? Maybe the epileptic conditions it treats are too rare to be interesting research targets? This sounds kind of suspicious.
(Score: 1) by khallow on Wednesday June 27 2018, @11:17AM
Why develop a drug that you know from the start is going to be excluded from the most profitable market in the world?