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This Is the First FDA-Approved Medicine Derived From Cannabis

Cannabidiol, recognized by most states as a treatment for epilepsy, now has the federal government's blessing.

GW PharmaceuticalsGW PharmaceuticalsYesterday the Food and Drug Administration approved Epidiolex, an oral cannabidiol solution made by the British company GW Pharmaceuticals, as a treatment for two forms of severe, drug-resistant 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.

The plant itself is still listed in Schedule I of the Controlled Substances Act, meaning it has a high potential for abuse and no accepted medical use. In light of the FDA's decision, that designation is clearly no longer appropriate for cannabidiol (CBD), which is not psychoactive but has shown much promise as a medicine.

Patients who received CBD in three randomized, double-blind clinical trials saw much bigger improvements than patients who received placebos. In a study of 225 patients with Lennox-Gastaut Syndrome, for example, the median number of "drop seizures" (which can cause falls) during a 28-day period fell from 85.5 to 44.9 in the high-dose group (a decrease of 49 percent), from 86.9 to 50 in the low-dose group (43 percent), and from 80.3 to 72.7 in the placebo group (21 percent). In a study of 120 patients with Dravet Syndrome, the median number of convulsive seizures over 28 days fell from 12.4 to 5.9 in the CBD group (a drop of 52 percent) and from 14.9 to 14.1 in the placebo group (5 percent).

"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life," said Billy Dunn, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition."

Twenty-five of the 29 states that allow medical use of marijuana specifically recognize epilepsy as a qualifying condition. Another 17 states officially allow the treatment of epilepsy with low-THC, high-CBD cannabis oil, although they do not necessarily provide a legal way to obtain it.

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  • Just Say'n||

    All the advertisements for any drug derived from cannabis seems to be exclusively advertised on libertarian podcasts.

    "No, I will not buy your weed, Dave Smith"

  • Rockabilly||

    Only Goobermint knows what's best for you, a mere citizen.

  • Echo Chamber||

    "marijuana's main psychoactive ingredient has been legally available as a treatment for ... appetite loss since 1985"

    That must have been one of the most obviously successful clinical trials to ever make its way through the system.
    Does that hake THC a low-hanging fruit?

  • Echospinner||

    Marinol is a synthetic oral THC compound. Thus very expensive. It does not work very well compared to actual cannabis. Ask any oncologist. Most will hint to patients that some pot would help with the nausea and lack of appetite.

  • Diane Reynolds (Paul.)||

  • Juice||

    GW Pharma is small cap.

  • SQRLSY One||

    God / Nature / Karma / Evolution gives us a drug that works!!!!! It must be outlawed; the right people are NOT making a profit!!!

    Add some Government-Almighty-blessed PhD chemists and FDA fat-cats to bless it, by tweaking the molecular mix a tiny-tiny bit.... AND GETTING SOME PATENTS!!!! And suddenly it is all cool!!!

    It reminds me of the 1970s, when Government Almighty offered "incentives" for chemists etc. to "clean up" coal, make it more "clean" and "efficient''', via modern chemistry... So coal sellers and processors were adding as few sprinkles of salt here, a few squirts of mustard there, to the megaton of raw coal... AND GETTING BREAKS FROM THE FEDS FOR "RE-FORMULATED COAL"!!!!

    Same thing here now, is what we are looking at...

  • LarryA||

    So all this time (decades) that they've been saying "Pot has no medical use so we don't have to allow research," they've been either dead wrong or outright lying?

  • ||

    either dead wrong or outright lying?

    Yes, and yes.

  • BestUsedCarSales||

    The latter. That argument is an obvious logical fallacy, so obvious that even government can see it. So it's just pure malice and inertia.

  • ||

    Yesterday the Food and Drug Administration approved Epidiolex, an oral cannabidiol solution made by the British company GW Pharmaceuticals, as a treatment for two forms of severe, drug-resistant epilepsy.

    This means that by definition marijuana is no longer Schedule 1 under the Controlled Substances Act, right?

    Right?

  • Echospinner||

    They will reclassify CBD. The plant will stay schedule 1. Thus preventing further research until they are forced by pressure and evidence to admit that they were wrong all along.

  • Telcontar the Wanderer||

    In a study of 225 patients with Lennox-Gastaut Syndrome

    So named, I assume, for its having first been contracted by overworked terraformers on the colony planetoid MW-537.

    Lennox-Gastaut: Creating Better Planets, Whatever It Takes

  • Dan S.||

    How is this different from CBD oil that you can get on eBay?

  • Paloma||

    Perhaps more concentrated canibanoids? Online is typically 3.5% or so.

  • Echospinner||

    Who knows but this is much bigger. This company actually threw the FDA down. The evidence was so compelling in clinical trials that there was no point in continuing them.

  • Amir Najam Sethit||

    Lets see how it affects to the patients.

  • IceTrey||

    Oklahoma passed medical cannabis!!!

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