Current Events > First ever marijuana-based drug submitted to the FDA for approval.

(+) Yeah! (+)

A prescription medication made from marijuana might be approved by the Food and Drug Administration this summer. The advance could be a huge step forward for people with epilepsy, which this drug treats. And it would signal a newsome would say long-delayedembrace of cannabis-based medications in the U.S.

GW Pharmaceuticals, the company behind the drug, started the approval process with the FDA last year, and a study published this week offers more encouraging signs.

The medication under investigation is made of cannabidiol, or CBD. In a study published Wednesday in The Lancet, researchers gave either a brand name form of CBD called Epidiolex or a placebo to more than 170 people with Lennox-Gastaut syndrome, a rare, severe and difficult-to-treat form of epilepsy. Adding CBD to other anti-seizure medications cut down on the number of seizures a person experienced each month by 41 percent. By contrast, the placebo reduced the number by about 14 percent.

Its very exciting that it shows efficacy, said one of the researchers, Dr. Elizabeth Thiele, the director of the pediatric epilepsy program at Massachusetts General Hospital. And of course theres been a huge amount of interest because its cannabidiol.

Up until the 1800s, neurologists would use cannabis to treat conditions including epilepsy, Thiele told Newsweek. But in the 20th century, federal and state governments clamped down. In the 1970s, the Controlled Substances Act made studying marijuana-related compounds nearly impossible.

Some treatments have circumvented regulatory roadblocks. The FDA approved two versions of tetrahydrocannabinolthe chemical that results in a highas nausea treatments. But those are synthetic compounds; they aren't made from the plant itself. Epidiolex would be the first plant-derived approved drug and the first approved cannabis-derived treatment for epilepsy. Its going to be kind of tragic that all of this was put on hold for decades, Thiele said.

Finding a way to keep epilepsy under control can be life-changingor even life-saving. Injuries can happen during seizures. People with uncontrolled seizures can't drive. Epilepsy has even been associated with sudden and unexplained deaths.

Thiele doubted any neurologist in the country hadnt heard a request for medical marijuana lately. CBD-heavy products can be found on the market alreadytheyre part of the treatment regimen for Alexis Bortell, the 12-year-old girl suing the federal government over marijuana policy. But they always include other chemicals in marijuana.

Epidiolex is an extract. "This is purified CBD, Thiele said. And that purity makes the compound more palatable for regulatorsand doctors. Every time I give a kid a dose of [Epidiolex], I know exactly what theyre getting. Theyre not getting all the other chemicals. (Thiele has worked with GW Pharmaceuticals, the company making Epidiolex, for four years; the company funded the study.)

The findings from the new study didn't surprise Dr. Jerzy Szaflarski, the director of the epilepsy center at the University of Alabama at Birmingham . Other CBD trials conducted in recently for epilepsysome using Epidiolexshowed similar results. Epidiolex has also been studied in people with another severe form of epilepsy, Dravet syndrome.

The FDA may decide not to approve Epidiolex; the agency has until June 27, 2018 to decide based on data from trials including this one. Nevertheless, Thiele is optimistic. Hopefully, it will be approved, she said. Patients want it.


Full Article: https://www.goodnewsnetwork.org/first-ever-cannabis-based-drug-submitted-fda-approval/



Millions of conservatives just got mad and millions of liberals just got euphoric.
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Good, now they need to make an anti-depressant/anxiolytic that doesn't break your dick and turn you into a psychopath.
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3deep5u posted...

Good, now they need to make an anti-depressant/anxiolytic that doesn't break your dick and turn you into a psychopath.

wut
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Marinol has existed for quite some time already, though.

Step 1: ban marijuana
Step 2: this
Step 3: profit

I wonder how many are invested in for-profit prisons and this company
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3deep5u posted...

Good, now they need to make an anti-depressant/anxiolytic that doesn't break your dick and turn you into a psychopath.

And they need to stop selling lethally addictive opioids over the fucking counter to everyone too.
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UnfairRepresent posted...

3deep5u posted...

Good, now they need to make an anti-depressant/anxiolytic that doesn't break your dick and turn you into a psychopath.

wut

https://www.youtube.com/watch?v=XFLQBUDa0uw
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gunplagirl posted...

Step 1: ban marijuana
Step 2: this
Step 3: profit

CBD has a pretty niche market, and doesn't have any of the "fun" of THC. The most we'll get is the occasional article about it being $1500 a dose or something.

Questionmarktarius posted...

gunplagirl posted...

Step 1: ban marijuana
Step 2: this
Step 3: profit

CBD has a pretty niche market, and doesn't have any of the "fun" of THC. The most we'll get is the occasional article about it being $1500 a dose or something.

Granted, but my concerns are
A) chronic pain sufferers who will have this covered by insurance but not medical marijuana, and it'll be insufficient in terms of easing pain. By that, I mean the fact that some chronic pain sufferers can't eat even with other heavy duty pain killers because they don't inhibit hunger like marijuana
And
B) there will still be people (primarily men of color) arrested for using a substance that based on any recent and useful study, demonstrates it isn't harmful on adults and doesn't even affect your basic functionality at nearly the same degree as alcohol. The fact these alternatives will be made is only to keep up profit margins.
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UnfairRepresent posted...

3deep5u posted...

Good, now they need to make an antidepressant/anxiolytic that doesn't break your dick and turn you into a psychopath.

wut

common side effects of anti-depressants are pilldick (makes it mad hard to ejaculate or kills your already low sex drive) or if you're really unlucky, they fuck with unstable emotions in a baaad way. shits different for everyone though, and i've already found an antidepressant in pill form that has neither of those effects, but I've certainly been through them in the past.
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Back_Stabbath posted...

UnfairRepresent posted...

3deep5u posted...

Good, now they need to make an antidepressant/anxiolytic that doesn't break your dick and turn you into a psychopath.

wut

common side effects of anti-depressants are pilldick (makes it mad hard to ejaculate or kills your already low sex drive) or if you're really unlucky, they fuck with unstable emotions in a baaad way. shits different for everyone though, and i've already found an antidepressant in pill form that has neither of those effects, but I've certainly been through them in the past.

https://www.youtube.com/watch?v=7_zKT3fa-mU

Not antidepressants but those have equally bad side effects.
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