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FDA Approves Trials For Marijuana-Based Epilepsy Medicine

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FDA medical marijuanaCourtesy of The Joint Blog

The U.S. Federal Drug Administration has given unprecedented approval for two separate trials of Epidiolex, a liquid medicine made entirely of cannabis; the substance contains 98% cannabidiol, a nonpsychoactive compound found in cannabis – the remaining 2% consist of various trace amounts of other cannabinoids.

The studies will be led by Orrin Devinsky, MD at New York University’s School of Medicine, and Roberta Cilio, MD, PhD, at the University of California.

Each study will involve 25 participants, all children.

Epidiolex is manufactured by GW Pharmaceuticals, the company behind Sativex, a cannabis-derived medicinal spray which has been approved for treating multiple sclerosis in multiple countries, including Canada.

According to Geoffrey Guy, MD, chairman of GW Pharmaceuticals, cannabidiol is more than just an anti-seizure agent. “It’s anti-inflammatory, neuro-modulatory, and has been shown in animals to counter neonatal hypoxic ischemia [oxygen starvation during delivery]—an important problem you see after seizures in these children.”

Source: TheJointBlog.Com

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17 Comments

  1. A note to future readers, it appears the definition of “synthetic” is debatable in some circles.

  2. Cannabis products produced by big pharma are all synthetic, at least to my knowledge. They will help some people, but not as many as the true bud.

  3. I assume both Epidiolex and Sativex are plant extracts. If so then the fda needs to approve both of them. The US needs to get up to speed on this. Its way past due IMO.

  4. With the death toll consistant at zero and people, like myself, obtaining natural relief from ailmants like seizure disorders it’s clear to see marijuana is medicine.

  5. Apparently someone forgot to tell the FDA, Pharma Lab, MD and the PhD that the cannabis community of the planet has already had their own trials and found the health benefits of cannabis to be overwhelmingly positive. I’ll go right to the obvious experts – a reputable cannabis dispensary. Big drug company not needed.

  6. Smoking/ vaporizing will always be the best way to get the correct dose. The government will never admit this, therefore, full legalization is still the answer.

  7. I hate to whine. Things will only move when pharma/wall street/Holder/Obama agree on $$$$$$$$$$$$$$$$$$$$$$$ and next election.

  8. A cannabis study with all children. Seems Dr. Gupta’s message is ringing bells somewhere.
    It seems logical that the FDA will only “approve” studies that are linked with pharmaceutical companies with patent protection for their product. At least when it comes to drugs.

  9. We cannot get rid of the schedule one status until the FDA does… something. My understanding is that all activist roads eventually lead to the FDA.

  10. I think marijuana should be legal for all adults. It has never killed anyone but everything else that is legal has. Plus I work all day take care of my family if I want to smoke then who is it hurting the consequences of getting caught with it out way the effects by far.Just away for the government to make money off everyday people while wasting tax dollars trying to find it and in the mean time letting drug lords be encharge of how people get it. It a plant get over it . If u believe in god and think we know more about whatwe should have on this earth than he does may he have mmercy on Ur soul. Bp

  11. Its for IND(Investigational New Drug) status. That means its still a long way off to helping any significant number of people. After its an IND and they get positive results then they will go for NDA(New Drug Application). There is still tons of paperwork and red tape even if it gets fast tracked in the USA.

  12. No, no no, this is NOT good news! Whenever Big Pharma comes out with a marijuana based drug made in a lab, that will only give more ammo to the drug warriors who want to take away the real thing (meaning the actual plant, the buds, the strains, the brownies, the homegrows and the mom and pop dispensaries in the states that have them). This is only going to be used as an excuse to take away the real medical marijuana which they say is “not real medicine”! They dont want you to use a natural plant, only chemicals made in a lab is “real medicine” to them.

  13. This has huge ramifications, does it not? If the FDA finds medicinal uses for cannabis, doesn’t that mean that the schedule one status no longer applies?

  14. Fantastic!!! Great news all around not only for epilepsy patients and thier families but for the many people who can benefit from this amazing plant. And of course the entire cannabis reform movement. Let’s hope for favorable results and other studies to follow.

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