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Epidiolex By Gw Pharm For Epilepsy


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This seems to be getting fast tracked on a compassionate need basis.

 

Comes Now Epidiolex™ (FDA approves IND studies of CBD)

By Fred Gardner  October 22, 2013 

In response to urgent need expressed by parents of children with intractable epilepsy, the U.S. Food and Drug Administration is allowing Investigational New Drug studies of purified CBD (cannabidiol) as an anti-seizure medication. The “new drug” is being provided to physician-investigators by GW Pharmaceuticals, which has named its CBD product “Epidiolex™.” 

To date FDA has approved intermediate-sized INDs sponsored by Orrin Devinsky, MD, at the NYU School of Medicine, and Roberta Cilio, MD, PhD, at UCSF —each set up to follow 25 patients using Epidiolex™ as a treatment for pediatric epilepsy— plus two individual INDs by Cilio. More INDs await FDA approval. [style note: the jargon calls for dropping the word "study" after IND, just as the word "proposal" gets dropped when researchers speak of "writing a grant.”] Devinsky and Cilio both made presentations at a conference on “Cannabidiols: potential use in epilepsy and other neurological disorders,” held at NYU October 4.

GW chairman Geoffrey Guy, MD, says, “In the coming months, if the FDA is comfortable about how things are going, there will be a number of senior epileptologists in major university centers throughout the U.S., each treating a couple of dozen patients with various epilepsies.”

Each physician-sponsored, intermediate-sized IND can enroll additional patients, with FDA approval. Given the level of need and the efficiency.   (see link for more)

 

 

 

http://www.beyondthc.com/comes-now-epidiolex-fda-approves-ind-studies-of-cbd/

 

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LOL,it's a British company.And the FDA does NOT approve new drugs quickly.We have many anti seizure meds already,Neurontin,Lyrica.The original use of these drugs was for treating epilepsy,and now is being used for fibromyalgia and other neuropathy pain. I wouldn't count on any quick FDA approval on this one. Why do we need any SYNTHETIC form of MJ when it grows out of the ground? Do you trust the FDA?

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LOL,it's a British company.And the FDA does NOT approve new drugs quickly.We have many anti seizure meds already,Neurontin,Lyrica.The original use of these drugs was for treating epilepsy,and now is being used for fibromyalgia and other neuropathy pain. I wouldn't count on any quick FDA approval on this one. Why do we need any SYNTHETIC form of MJ when it grows out of the ground? Do you trust the FDA?

It is a British company.  Why is that funny?  This company seems to be much further along than US pharmaceutical companies with respect to cannabis research. 

 

Check out the performance of stock ticker GWPH over the last few months.  The investing community is taking notice and the stock has risen from under $9 to over $30 in the last few months.

 

If it is 'for the children', anything can happen.  Don't be too shocked to see this one get FDA approval relatively quickly. 

 

Also, as Grassmatch mentions, this is not a synthetic.

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some interesting facts about them;

 

In the annals of medical-marijuana history, it was a significant moment: In June 1998, British regulators granted GW Pharmaceuticals a license to cultivate and supply marijuana for research and pharmaceutical development. There was just one problem: Where in the world would Geoffrey Guy, GW's founder and chairman, find a legal source of pharmaceutical-grade marijuana seeds -- enough to grow "tons" of material? Someone in England's Home Office gave Guy a tip: A reclusive Dutch company called Hortapharm, founded by two Californian expatriates, might be able to help him out.

In the world of ganja connoisseurs, Hortapharm's founders -- David Watson and Robert Clarke -- are near-gods. Clarke, Hortapharm's principal botanist, is the author of Marijuana Botany and Hashish!, the first serious, science-based books on cannabis cultivation for a counter-culture readership. Watson, the company's CEO, traveled to nearly every marijuana-rich country on the planet and assembled what is arguably the world's most comprehensive cannabis-seed library. Allen St. Pierre, executive director of the National Organization for the Reform of Marijuana Laws, credits Watson with "almost single-handedly preserving hundreds of strains of cannabis."

When I met Watson in his office in a residential neighborhood in Amsterdam, he presented me with two marijuana seeds. One seed, from Kashmir, was the size of a pinhead -- "wild ditch weed, wannabe marijuana," Watson called it. The other was a hemp seed, as fat as a lentil. The seeds could easily have symbolized the breadth of his study of Cannabis sativa.

Watson has a linebacker's build and a crooked, Jack Nicholson smile. On the subject of cannabis, he is ferociously opinionated, frequently punctuating his assertions with an in-your-face refrain: "Do you understand?" What follows are excerpts from a lengthy interview, in which he describes how he and Clarke came to be two of the pioneering entrepreneurs in the Aboveground Marijuana Economy.

What drove you to collect cannabis seeds?

I had a jewelry and clothing import business during the 1970s and early '80s, and I did a lot of traveling throughout Asia. While I was in India, I became aware of Ayurvedic medicine, which still uses cannabis to treat a wide variety of illnesses. I've always had an interest in seeds -- I'm a lifetime member of the Seed Savers Exchange in the US -- and I began collecting cannabis seeds to see how different strains might be used for different medical applications. I also saw how eradication efforts by international law enforcement agencies were having a negative effect on the very high end of the gene pool. I wanted to collect that high end before it was lost. I collected in Mexico, South Africa, Thailand, Colombia -- thousands of strains from dozens of countries.

How would you find the seeds that you wanted?

It depends. If it's during the growing season, you might be able to make contact with an illicit farmer. If it's out of season, you've got to connect with a person who sells illegal cannabis. I've walked into pharmacies and asked, "If I was interested in getting seeds from the cannabis plant for making medicine, where would I get them?" In south India, I notified the police that I was collecting and one of them gave me a plant as a present! My goal was to collect all of these genetics worldwide. It wasn't easy -- sometimes you have to step into harm's way to get the goods.

What kind of a plant would you look for?

In general, you're looking for a clean genetic profile -- the ability to produce the compound you're after. And you want a plant that's producing lots of flowers -- lots of resin. If the plant doesn't have a lot of resin on it, it's probably not going to have very much THC in it, even if the profile is incredibly clean. You need both.

The clones that people are using to produce illicit marijuana are by far primarily only THC [the psychoactive ingredient in marijuana]. They don't really have the other cannabinoids because year after year, recreational smokers have selected only for THC and rejected everything else. But because we're breeding for medicine, we're after THC and all the other cannabinoids. [Cannabis is comprised of 61 cannabinoids, complex molecules unique to the plant, of which THC is the best known.] I don't have any interest in collecting varieties that have been developed in the West by marijuana growers. They're just have the same old THC, which is what recreational smokers are looking for. I want varieties that have unusual characteristics in their growth or flowering period, or new and unusual sources of cannabinoids.

What led you to launch Hortapharm?

Our original business plan was to breed pharmaceutical-grade cannabis and use it to produce a cheaper, generic version of Marinol. [Marinol is a synthetic-THC tablet for treating nausea induced by cancer chemotherapy.] We knew we could produce pure THC from the plant, which is superior to a synthetic. I'm convinced that the synergistic effects of the full plant, which in its natural form produces 400 compounds, is far more medically beneficial that any single synthetic component.

We were going to knock our price down at least a third or more from Marinol's price tag. We thought that within a year or two, we could grab 66% of Marinol's $20-million market, which was enough to support our small company. But money wasn't the reason we did this. We were really interested in bringing cannabis back into mainstream medicine.

Given the drug laws in the United States, I guess you had no choice but to set Hortapharm up in the Netherlands.

We never could have carried out this activity in America -- we would have turned old and gray just waiting to do the work. So in 1994, we applied to the Dutch Ministry of Health for a license to cultivate cannabis. We finally got it in 1997, which made us the Netherlands' first legal operation to grow cannabis for pharmaceutical research. The application process was extraordinarily rigorous. I was shocked by how long it took. Holland has this rep as the marijuana capital of the world. But while it's true that you can buy a small amount in a coffee shop, the government is very strict with cultivation.

How did you go about growing pharmaceutical-grade cannabis, which must be standardized to be made into a medicine?

That's the thing. If you bought tomato seeds and grew 100 plants, they'd all come out the same. But if you bought cannabis seeds on the black market and grew 100 plants, you're probably going to get a lot of variation. Amateur growers just don't have a full understanding of how to breed. I had spent years collecting cannabis seeds worldwide. We grew thousands and thousands of those, analyzed them, and selected for the target compounds we really wanted. We grew the plants in a big glasshouse and we also grew outdoors, in secret locations.

[Watson displays a photograph of five acres of high-grade pot, cultivated for seed production, from "somewhere" in Europe.] After we extracted the seeds we wanted from this crop, we burned all five acres. My American friends were dumbfounded -- it would have been worth millions of dollars on the black market. But that's what plant breeders do -- we grow 100,000 plants, keep 100 of them, and trash all the rest. I love to kill. I'm getting rid of everything that's imperfect.

Okay, so you got the seeds you wanted. How did you then grow plants that were genetically consistent -- a prerequisite for producing medicine?

Cannabis is normally a heterozygote, which means it has two sets of chromosomes -- one from the mother and one from the father, and they vary. Through a proprietary technique we developed called selfing, we became the world's first breeders to develop homozygote cannabis, in which both sets of chromosomes are identical. We then mass produced plants with just the one cannabinoid profile we wanted. We grew plants that were 98% THC, or 98% CBD. And that's what Geoffrey Guy [founder of GW Pharmaceuticals] was looking for. He wanted different cannabinoids -- THC, CBD, CBC, CBG -- which he could then blend in different ratios and explore them for their medical efficacy. We were the only ones in the world who had what Geoffrey badly needed.

How did you meet Dr. Guy?

We had sent a representative to a meeting of the Multiple Sclerosis Society in England, which Geoffrey attended. We were the only people there that were supporting the U.K. government's position on medical marijuana, which was to take a step-by-step approach to studying the issue. Everybody else just wanted to legalize medical marijuana tomorrow. We felt it was better to test the materials first and put them through a normal drug-approval process. Our colleague impressed Geoffrey, and he contacted us.

When Geoffrey came over here in 1998, we were getting close to our financial limit. We're an R&D company -- we didn't have a product that was making an income. The problem for Geoffrey is that all cannabis experts have backgrounds -- they've built their expertise by working with an illegal material. But Hortapharm was fully licensed by the Dutch government. So Geoffrey got a legal supply of pharmaceutical grade germ-plasm. And he got me and Robert Clarke to pass along our knowledge. We gave him at least a five-year head start.

If Sativex, GW's cannabis-based medicine for treating MS symptoms, gets approved by British regulators, what effect will that have on the debate over medical marijuana?

It will prove to people, patients, and businesses that cannabis can be a valuable therapeutic agent. And once Sativex gets the go-ahead in the UK, it will quickly win approval in Europe, Canada, and Australia -- and the U.S. will be the one country to stand there and say, No, cannabis has no therapeutic application. But I don't think American scientists will stand for that.

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Otsuka Pharma is GW's US firm for their products.

 

 They have been known to have lobbyists go to legislatures and preach against "crude" cannabis that exists in "so called medical marijuana" state laws.

 

 

 *shrug*

 

 One of the reasons I get annoyed at dispensary people for making basement grown cannabis seem "crude, unsafe, untested, and not safe access".

 

 They are preaching an argument for the exact people that will run them out of business. ;-)

 

 

 

 12 plants. One Patient. Leave us Alone.

 

:-)

 

 A bit of a CPU motto.

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I'm thinking they're at the top of their game with knowledge, genetics, technology, and many patents, as well as policy along with cannabis products allowed to be mailed by special permits all around the world....... a huge leap from our country's permitted growers hiding in their basements in fear of  policy makers we fully support year after year. I don't see GW going away anytime soon, and in reality their progression may be the very science that puts us caregivers/patients out of the garden, and into the pharmacy.

Sam the Skunkman used to be one of us, now look at him ! Clarke wrote books we drooled over for decades while we dreamed of someday growing cannabis for ourselves. Now check him out !   Not sure if they sold out to big pharma/Monsanto, but they have given our vegetable matter a strong case for "known medical uses".

Basement growers would never be able to do the same type of clinicals, manufacturing, genetic diversity, or marketing that they have, so hats off to them, for now, from me. keep your eyes on Monsanto, the real king behind all that grows.

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I'm thinking they're at the top of their game with knowledge, genetics, technology, and many patents, as well as policy along with cannabis products allowed to be mailed by special permits all around the world....... a huge leap from our country's permitted growers hiding in their basements in fear of  policy makers we fully support year after year. I don't see GW going away anytime soon, and in reality their progression may be the very science that puts us caregivers/patients out of the garden, and into the pharmacy.

Sam the Skunkman used to be one of us, now look at him ! Clarke wrote books we drooled over for decades while we dreamed of someday growing cannabis for ourselves. Now check him out !   Not sure if they sold out to big pharma/Monsanto, but they have given our vegetable matter a strong case for "known medical uses".

Basement growers would never be able to do the same type of clinicals, manufacturing, genetic diversity, or marketing that they have, so hats off to them, for now, from me. keep your eyes on Monsanto, the real king behind all that grows.

 

The trouble is that the people who should know what Monsanto is up to (our elected "Representatives") are paid to keep their mouths shut and look the other way. They also divert attention from the real threats facing our society by producing straw dogs that they use to draw attention away from what is happening behind the scenes. Their duplicity is the real treason plaguing this country.

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I think that if there was a way to separate valuable components like cbd and other such components in a pure form there might very well be uses for that. Of course this is done for profit.i cannot see anything wrong for instance if a company made an extract from the plant that was pure that was proven to be the best application for a specific illness. To me the problem is that many of our bureaucrats define it as one without the other. As when they said why do you need medical mj when you have Marinol. a rather incomplete way of thinking. The idea is to do what works best for any one apllication in a wide variety of illnesses in which there might be many different viable approaches. I think that both approaches should be allowed and that since mj is far safer than alchohol its recreational use should be a matter of choice too. 

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Excuse me sir,I had to take Marinol after a large gut surgery because I could not eat for 5 days. I don't think the large teaching  Hospital I went to would let you puff one. Why don't you find out facts before you start to chastize someone you don't even know? I will be SURE to let my surgeon know that you didn't approve. Do you know what it is like to not be able to eat for 5 days after a surgery to remove your whole colon? The surgeon is the one that suggested the Marinol to give me an appetite. I am so sorry you do not approve.

Edited by jointedone
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I don't think that mrd was capping on you for choosing marinol, maybe reread his post for a better understanding. I got that he was referring to the poiticians who believe that there would be no reason for natural cannabis treatments while a synthetic version of a single cbd of cannabis exists. Most people are understanding that our healing may depend on the synergistic roles that a myriad of constituents can offer, rather than the patentable synthetic that can be so much more profitable to the companies that line the pockets of supported politicians via lobbying.

Surgeons recommend products that they are told to represent, by the companies that produce them. Med students are often funded by big pharma, and are bombarded with advertising in the very textbooks provided. High Cholesterol has become the fault of a Lipitor deficiency in our system of profiteering for example.

 

I am sorry you had such a bad experience and hope you heal well.

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indeed there is a way to "separate valuable components" in a pure form. I wish our Act was not challenged recently. We're now conveniently not even allowed to separate and purify as our act has been redefined to outlaw this needed purification, which will be the only way to derive the pure medicine the plant has to offer, nicely done Big Pharma. Synthetics door wiiiiide open in Michigan !

I think that if there was a way to separate valuable components like cbd and other such components in a pure form there might very well be uses for that. Of course this is done for profit.i cannot see anything wrong for instance if a company made an extract from the plant that was pure that was proven to be the best application for a specific illness. To me the problem is that many of our bureaucrats define it as one without the other. As when they said why do you need medical mj when you have Marinol. a rather incomplete way of thinking. The idea is to do what works best for any one apllication in a wide variety of illnesses in which there might be many different viable approaches. I think that both approaches should be allowed and that since mj is far safer than alchohol its recreational use should be a matter of choice too. 

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I don't think that mrd was capping on you for choosing marinol, maybe reread his post for a better understanding. I got that he was referring to the poiticians who believe that there would be no reason for natural cannabis treatments while a synthetic version of a single cbd of cannabis exists. Most people are understanding that our healing may depend on the synergistic roles that a myriad of constituents can offer, rather than the patentable synthetic that can be so much more profitable to the companies that line the pockets of supported politicians via lobbying.

Surgeons recommend products that they are told to represent, by the companies that produce them. Med students are often funded by big pharma, and are bombarded with advertising in the very textbooks provided. High Cholesterol has become the fault of a Lipitor deficiency in our system of profiteering for example.

 

I am sorry you had such a bad experience and hope you heal well.

Yes that is exactly what I meant. Although I do feel there are many people me for one who take statin drugs and it is beneficial. Although they should not be viewed as an excuse not to exercise and eat properly. Thanks for standing up for me. Best regards. 

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