Nov 162013
 November 16, 2013

FDA medical marijuana epidiolex gw pharmaceuticalsHow do you feel about the pharmaceutical industry entering the medical marijuana scene? Do you think that a pharmaceutical company can produce better medical marijuana products than what are currently out there? Are you scared of a pharmaceutical takeover of the medical marijuana industry? A major pharmaceutical company received approval this week from the Food and Drug Administration (FDA) for a plant derived medicine called Epidiolex. Do you think this is good or bad? Do you think it will increase support for cannabis research by our federal government? Below is a press release from GW Pharmaceuticals, the creator of Epidiolex:

GW Pharmaceuticals plc (AIM: GWP, Nasdaq: GWPH, “GW”) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Epidiolex®, our product candidate that contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Dravet syndrome, a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome. Epidiolex is an oral liquid formulation of a highly purified extract of CBD, a non-psychoactive molecule from the cannabis plant. Following receipt of this orphan designation, GW anticipates holding a pre-IND meeting with the FDA in the near future to discuss a development plan for Epidiolex in Dravet syndrome.

Dravet syndrome is a rare pediatric epilepsy syndrome with a distinctive but complex electroclinical presentation. Onset of Dravet syndrome occurs during the first year of life with clonic and tonic-clonic seizures in previously healthy and developmentally normal infants. Prognosis is poor and patients typically develop intellectual disability and life-long ongoing seizures. There are approximately 5,440 patients with Dravet in the United States and an estimated 6,710 Dravet patients in Europe. These figures may be an underestimate as this syndrome is reportedly underdiagnosed.

In addition to GW’s clinical development program for Epidiolex in Dravet syndrome, which is expected to commence in 2014, GW has also made arrangements to enable independent U.S. pediatric epilepsy specialists to treat high need pediatric epilepsy cases with Epidiolex immediately. To date in 2013, a total of seven “expanded access” INDs have been granted by the FDA to U.S. clinicians to allow treatment with Epidiolex of approximately 125 children with epilepsy. These children suffer from Dravet syndrome, Lennox-Gastaut syndrome, and other pediatric epilepsy syndromes. GW is aware of further interest from additional U.S. and ex-U.S. physicians to host similar INDs for Epidiolex. GW expects data generated under these INDs to provide useful observational data during 2014 on the effect of Epidiolex in the treatment of a range of pediatric epilepsy syndromes.

“I, together with many colleagues in the US who specialize in the treatment of childhood epilepsy, very much welcome the opportunity to investigate Epidiolex in the treatment of Dravet syndrome. The FDA’s timely approval of the orphan drug designation for Epidiolex in Dravet syndrome is a key milestone that comes after many years of reported clinical cases that suggest encouraging evidence of efficacy for CBD in this intractable condition,” stated Dr. Orrin Devinsky, Professor of Neurology, Neurosurgery and Psychiatry in New York City. “With GW now making plans to advance Epidiolex through an FDA development program, we have the prospect for the first time of fully understanding the science of CBD in epilepsy with a view to making an appropriately tested and approved prescription medicine available in the future for children who suffer from this debilitating disease.”

“GW is proud to be at the forefront of this important new program to treat children with Dravet Syndrome and potentially other forms of intractable childhood epilepsy. For families in these circumstances, their lives are significantly impacted by constant and often times very severe seizures in children where all options to control these seizures have been exhausted,” stated Dr. Stephen Wright, GW’s R&D Director. “GW intends to advance a full clinical development program for Epidiolex in Dravet syndrome as quickly as possible, whilst at the same time helping families in the short term through supporting physician-led INDs to treat intractable cases. Through its efforts, GW aims to provide the necessary evidence to confirm the promise of CBD in epilepsy and ultimately enabling children to have access to an FDA-approved prescription CBD medicine.”
“This orphan program for Epidiolex in childhood epilepsy is an important corporate strategic priority for GW. Following receipt of today’s orphan designation, GW now intends to commence discussions with the FDA regarding the US regulatory pathway for Epidiolex,” stated Justin Gover, GW’s Chief Executive Officer. “GW intends to pursue this development in-house and retains full commercial rights to Epidiolex.”

About Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition – generally a disease or condition that affects fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication.

About GW Pharmaceuticals

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional clinical-stage cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), Type 2 diabetes, ulcerative colitis, glioma and schizophrenia. For further information, please visit www.gwpharm.com.

Powered by

About Johnny Green

Johnny Green is a marijuana activist from Oregon. He has a Bachelor's Degree in Public Policy. Follow Johnny Green on Facebook and Twitter. Also, feel free to email any concerns.
  • Cherokee

    The FDA giving the green light for this means they must change Marijuana from a schedule 1 drug to something more realistic. This refutes the governments claim that Marijuana has no medicinal value.

    • Closet Smoker

      I fear that since this is a compound derived from the plant, not the plant itself, the Death for Everyone Administration (DEA) will say the whole plant has no medicinal value, regardless if compounds within are found with irrefutable proof (in the eyes of the Death for Everyone Administration) actually do, to justify their schedule one status and to keep their drug war going. Prohibitionists are not going to roll over without fighting for every mm of ground.

      • Cherokee

        Good points, those are valid fears and concerns. Thanks for your thoughts

      • Tony_Aroma

        By definition (in the Controlled Substances Act), anything that comes from the cannabis plant is a schedule 1 controlled substance with no medical use (see below). Marinol is one thing, it’s synthetic. But I don’t see how the feds can allow this without either rescheduling cannabis, or setting themselves up for more lawsuits, not to mention being even MORE hypocritical.

        Sec. 19. “Marijuana” means any part of the plant genus Cannabis whether growing or not; the seeds thereof; the resin extracted from any part of the plant, including hashish and hash oil; any compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. It does not include the mature stalks of the plant; fiber produced from the stalks; oil or cake made from the seeds of the plant; any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom); or the sterilized seed of the plant which is incapable of germination.”

        • Closet Smoker

          I am sure the spinmiesters can write policy so that pharmacutically extracted compounds made by patented means are allowed while keeping the rest as status quo…… there, Big Pharma gets to keep its billions, we don’t get herbal cannabis.

          • DMR

            This is precisely what our government has done to GW Pharma’s ‘sativex’ product here in the UK. Cannabis remains a Class B drug while sativex was rescheduled to a Schedule 4 drug, on the claims it doesn’t get patients high (I hear it does)

        • jay

          it would be an absolute budgetary fiasco if they went by that law… they would be throwing away every bit of that plant that has high cbd content…. it inevitable that there will be a law change

      • jay

        the point being , a drop in schedule class means access to research labs for every tom dick and harry…. this absolutely proves the scheduling predicament as ridiculous

  • AOrange

    Yes they are more than capable of identifying and isolating compounds, more than capable of producing safe forms. Will they? Who knows, but we’ve seen how science like this turned coca and opium poppys from medicinal plants to incredibly addictive and dangerous. As long as no known compounds for physical addiction exists in the plant we should be okay. Handled correctly and millions of lives improve, get it wrong and it who knows?

  • Mary Alice Frank

    And the big pharmaceutical companies will win again. This will make the price of beneficial marijuana sky high.

    • Bo Trytis

      Calm down Mary, once the tax base on marijuana finds its happy medium it should stay at the current price people pay right now and get cheaper as more is produced, if not the black market will exist. People will not support sky high pricing

      • Doc O’Zee

        Vince got your back!

      • Mary Alice Frank

        Well I guess you are right about the tax base. I wonder; will be as gas and tobacco tax? Will hemp be distinguished from marijuana allowing farmers to produce viable crops? I support the use of hemp to be used in all capacities to helping save our planet. Thanks for your reply Bo Trytis

        • Bo Trytis

          Thanks also for your intelligent input Mary, unlike some who like to stir up shit and call people names. I too share your valid concerns about big pharma. I’m with you on whatever good cannabis can do to help this planet.

          • Mary Alice Frank

            Thanks for supporting my concerns. It is said “baby steps” should be taking in gaining a goal; a giant leap should be the next step in the goal for going “GREEN”.

      • Doc O’Zee

        “once the tax base on marijuana finds its happy medium”
        With what frequency do taxes ever get reduced? And how does that compare to the frequency of taxes getting raised?

        “It should stay at the current price people pay right now and get cheaper as more is produced”
        Exact same line of bullshit the privatizers of alcohol said.
        And how did that go? (not that I personally care)

        Your arguments flawed from my perspective. I’ll calm down now.

    • Doc O’Zee

      Good chance that will be the case for the most select products of high demand.
      People who open replies with calm down … so paternal and somewhat assholeish, no?

      • Vincent Nibblin

        Speaking of assholes, who asked you for your opinion?

        • Doc O’Zee

          Ask? Pfft .Dole opinions out free with all kind of arrogance … just like YOU!

          :)

      • Mary Alice Frank

        This doesn’t even make sense; are you drinking alcohol?

        • Doc O’Zee

          I was concurring with your pricing concerns. So please tell me why it doesn’t sense.

    • Laura Driggers

      Big pharma, big governent, and doctors are all in bed with each other. They want the credit and the profits. We the people must stay on top of this matter.

  • hempangle

    Did anyone notice how fast they made this drug.It’s because they have had the plans for years and they were just waiting for a chance to throw it into the works.This is a good time to buy some stocks folks.

    • painkills2

      Sure, if you trust the stock market and Wall Street…

    • Sarijuana

      I don’t think they just came up with it that fast, but I sure agree about the stock. Wishing for a crystal ball!

  • Don Ward

    Yea its about time to allow children who are in desperate need of a cure. To let a child suffer, or to see a child normal, loving and caring…. wow what a difference between right and wrong!

  • Rob

    This looks like a tactic to slow or halt Medical marijuana. If this drug works then the pro-medical marijuana activists won’t have sick children to use to convince people of marijuana’s efficacy and change minds.

    • painkills2

      This approval by the FDA is very limited in scope and only addresses severe cases of epilepsy. Since cannabis treats so very many medical conditions, there will be plenty of sick people available to change minds, as is already happening.

      • Rob

        I think you miss the point. Most prohibitionists always pull the “To protect the children” defense for prohibition. Now the pro-marijuana movement has a “for the children” counter argument with the sick children and medical marijuana. The biggest group against us are the senior citizens and using cannabis to treat them is a big head turner and changes mind fast. Nobody can look at footage of Charlotte Figi having seizures and then see her playing, smiling and riding horses after getting her medical marijuana extract.

        • painkills2

          I’m really trying hard to see the point, but yes, I think I’m still missing it.

          You’re comparing the prohibitionists’ argument that legalization would cause an increase of cannabis use in children, to the pro-marijuana argument that cannabis can be used to treat medical conditions in children?

          The biggest group against us is not senior citizens in general, it is those with a right-wing ideology that says everything that is illegal should stay illegal. They think that they will be victims of increased criminal activity surrounding legalization. They are ruled more by fear than by fairness. Loyalty to this ideology is more important than learning about the history of cannabis. So these people will look at Charlotte Figi and be amazed, they might even have family members that partake, but they will not change their minds about the illegality of ALL drugs (except alcohol, caffeine and cigs of course).

          • Sarijuana

            I’m not convinced about the right-wing theory. I think many senior citizens are coming from a time and mindset that put doctors on a pedestal, and believe they always know what is best for their patient. Not many will venture out to find something different. I spend time with seniors nearly every day and try to spread the good word about marijuana. Most have very receptive ears, but find it hard to believe their government is hiding something. A few of them have taken my suggestion to talk to their doctor about marijuana, and at least one I know of was referred to a MC doctor here in town. They just need educating, like the doctors. If light is shed to all their eyes by this drug, and more to come, I believe that’s a good thing. I hope I’m right. If they don’t live in a legal MM state, most grannies and grandpas are not going to get a chance to find out for themselves unless they have a compassionate friend or family member to find weed for them, and then coach them on how to use it.

          • painkills2

            It is hard to generalize and be right, eh? I’ve read that the baby boomer generation is more receptive to marijuana in general, which seems to be part of the reason there is more acceptance these days. And yet some seniors need that “proof” from the FDA or the government. They don’t seem to understand the level of corruption that has invaded the medical industry and the government agencies that work within it. Which is weird, since they accept conspiracy theories that have no basis in fact for other areas of the government.

            And doctors have had a good ride while partnering with big pharma, and I doubt most of them are ready to give that up. Doctors are smart enough to understand the benefits of cannabis and if they don’t, they are just not trying hard enough. Or money and ideology are blocking their view.

          • Sinsibility

            The real truth is that all of the anti-legalization effort these days comes from the entrenched interests that profit from the status quo. And they are fighting for their lives now.
            Right now is the time for us stand together and demand that everyone gets over
            their Nixon/Reagan modern day reefer madness.

          • painkills2

            If we are aware of all the anti-legalization players, we will be better prepared to fight. We need to watch our backs and our sides, in case the antis drum up support from industries and players that we can’t see. That want to be hidden.

  • painkills2

    I will be very curious to see what the warning label says for Epidiolex.

    • Laura Driggers

      It couldn’t be any worse than the current FDA approved AED’s.

      • painkills2

        Sorry, I don’t understand the comparison. I just wonder what language (if any) the warning labels will carry, as decided upon by the FDA. We will be able to compare any warnings in current cannabis studies of the real thing against whatever warnings the big-pharma brand will carry. Or did you really want to talk about AEDs?

  • Obsolete

    Oh now it’s ok as long as you buy it from this company what about those that can’t afford to pay then you have to pay to visit your doctor it’s a plant let everyone grow it and use it you shouldn’t have to pay for something that grows natural think of the money that could go torward the economy if it was just legal to grow for yourself so it still boils down to the money it’s realy not about them approving it to help the kids its just for them to make this company and the government money

    • Sinsibility

      Sadly, you’ve articulated the underlying problem. This has become a fascist country, where business runs government. And government regulation is the only way to keep them under control.
      Not all the way to communism, where government runs business, but at least back to before the
      revolving door of CEO to government department head.

  • Mary Jane

    Why do we keep asking the government to do more research? They patented cannabinoids a decade ago. Wouldn’t that suggest they’ve done lots of research already? Maybe we should be asking them to stop holding out on what they already know instead. Even better, let’s start DEMANDING that they quit with the lies, greed and attempts to keep us brainwashed!

    • Alexandra Carlos Guzman III

      You have hit the nail on the head Mary Jane. It would take activism to possibly put the pressure on these bureaucrats,lobbyists and drug companies. This might be best achieved by a strategy whereby people who have used marijuana to counter debilitating conditions could testify as to its helping them in its current form. This would undermine the attempts to try a sythetic that has had dubious success from what I have been hearing. The older population in the United States are still hanging on to the antiquated notion of “REEFER MADNESS” when in fact no one in recorded history as ever died from using cannabis.

    • http://www.drmicheleross.com/ Dr. Michele Ross

      i’m a neuroscientist who’s studied cannabinoids. They have been doing tons of cannabinoid (not cannabis) research here in the states. They will never do cannabis research because pharmaceuticals are more profitable and easier to regulate. Marijuana has a black market and we can and will grow it ourselves. Thus, they’re going after the bigger market.

      • MrPC

        If the pharmaceutical companies can produce a controlled dosage, high-purity medication based on CBD to treat a specific disease or symptom, that’s great! They will probably have big, immaculate greenhouses that produce plants we would consider useless. I believe recreational cannabis will be more like the wine business than big pharma.

  • Mickey Dowling

    These Medi Quacks could not create a plant that can compete with my wifes green thumb.

    • Laura Driggers

      Hell to the yes!

  • Toughy

    Why not? Come on, CBD works – watch a child seizing up, you’ll feel very biased toward getting it out there. If it’s YOUR child you’ll be absolutely frantic to get CBD on drugstores shelves. The prospect of GW Pharmaceuticals making more $ leaves a sour taste but is someone going to synthesize it in their basement? We’ve used cannabis-based products for ages, here’s a chance to fund more research into its many benefits.

    • John Peterson

      we do not want a synthesized treatment . there is no reason to synthesize it . look at spice … marinol. One good thing is that GW IS NOT synthesizing if you read it says their product is CONCENTRATED CBD not Synthesized. Epidiolex is an oral liquid formulation of a highly purified extract of CBD. If you don’t know people do make it but usually not in their basements, its usually in the kitchen in a rice cooker with a cannabis / solvent mixture, and in fact if we were given he right to grow hemp and cannabis as we choose nobody would have to pay the pharmacy for their treatments..

      • JBs

        Rice Cookers/Solvent mixtures… nothing could go wrong there…

      • JBs

        Rice Cookers/Solvent mixtures… nothing could go wrong there…

      • http://www.drmicheleross.com/ Dr. Michele Ross

        The production of more extra-strength and unnatural cannabinoid-based pharmaceuticals will lead to more deaths like Marinol versus none cannabis. Oh, and does anyone remember Rimonabant, the CB1 antagonist sold in Europe as the most effective weight loss drug ever until the found out it caused suicide and depression and pulled it? The entourage effect of multiple cannabinoids, terpenes and flavanols in cannabis enhance bioavailability and prevent overdose. Natural is safer!

  • Nathan Arnold

    Another medical use accepted, but still blacklisted.

  • Sarijuana

    Baby steps, I guess. I have several ailments, and because I can’t find really high CBD weed, I’d love to have a pill I could take to address my RA flare ups, and perhaps that may come about from this scenario. My back pain and osteoarthritis is relieved very well from smoking just about anything and I’ll continue to do that, but it can’t touch the agony of an RA or Fibromyalsia flare up. The quest for breeding higher highs into the weed for decades has ignored the great potential of other constituents of marijuana. It’s unfortunate that big pharma may have a solution, but who’s bad is that?

    • painkills2

      I’ve been wondering if smoking the CBDs that inhibit inflammation is going to work. I’ve been keeping an eye out for reports from intractable pain patients that have successfully incorporated CBD-strength cannabis into their pain management routines, but the information is sketchy at best. I think when we’re talking about treatments for systemic inflammation, we need to look mostly at cannabis concentrates. Something taken orally and daily. Until it comes in a reputable pill form, looks like you’re stuck with making your own edibles, or using the available tinctures. Got an apron?

    • painkills2

      In my search through NM producers, I see that New MexiCann has a serious amount of high-CBD products.
      Opinion?

      • Sarijuana

        Looks like it’s time for a trip up to Fanta Se land.

        • painkills2

          But dude, it’s soooooo farrrrrrr… (Hey, remember that TV show Fantasy Island? Someone should re-make that into a reality show.)

    • painkills2

      In my search through NM producers, I see that New MexiCann has a serious amount of high-CBD products.
      Opinion?

    • http://www.drmicheleross.com/ Dr. Michele Ross

      There are ways to exponentially boost how much CBD hits your brain from the weed you already smoke or eat. I’m a scientist with years of industry experience with supplements, drug delivery and cannabinoids. I’m outraged that simple, cheap tricks that could reduce the need for expensive, high doses of CBD products are being hidden from the public. I’m trying to get funding to write my book so the sick people who need this medicine can actually afford it (including myself).

      • Sarijuana

        It takes forever to get a book published – if at all. Your blog addresses this? I’ll have to check it out.

    • shlala

      google “Charlottes web” “Stanley brothers”

      • Sarijuana

        yup. All over that. Need to whip up some RSO

  • Shawn Eddy-Wagenseller

    The Seattle Times has done a great job in reporting on ‘Orphan Drugs’. See part 2: Pharma’s Windfall http://apps.seattletimes.com/reports/pharma-windfall/2013/nov/9/seattle-biotech-orphan-drug/ and Part 1 link: Mining of Rare Disease. This is about BIG money and a way to game the system.
    In the mean time, getting valid exposure for this amazing plant’s capacity to heal is a good thing.

    • painkills2

      “There were about 2,000 rare diseases before the Orphan Drug Act. As of last month, there were 6,432, a Times analysis found.”

      I’m flabbergasted.

  • Tami Lucas

    Don’t trust Big Pharma

    If your doctor hands you a prescription for a
    fluoroquinolone antibiotic (this could be not only Cipro or Levaquin but also
    Avelox or generics ciprofloxacin, levofloxacin, and moxifloxacin, or others),
    be very certain that s/ your condition
    warrants the risks that come along with taking these drugs.

    http://www.lewrockwell.com/2012/10/joseph-mercola/antibiotic-alert-the-drug-the-doctor-ordered-could-cause-deadly-sideeffect

    The
    Fluoroquinolone Wall of Pain… Visit us at

    https://www.facebook.com/pages/The-Fluoroquinolone-Wall-of-Pain/209182505773463?ref=hl

  • Tami Lucas

    Don’t trust Big Pharma

    If your doctor hands you a prescription for a
    fluoroquinolone antibiotic (this could be not only Cipro or Levaquin but also
    Avelox or generics ciprofloxacin, levofloxacin, and moxifloxacin, or others),
    be very certain that s/ your condition
    warrants the risks that come along with taking these drugs.

    http://www.lewrockwell.com/2012/10/joseph-mercola/antibiotic-alert-the-drug-the-doctor-ordered-could-cause-deadly-sideeffect

    The
    Fluoroquinolone Wall of Pain… Visit us at

    https://www.facebook.com/pages/The-Fluoroquinolone-Wall-of-Pain/209182505773463?ref=hl

  • juniorspencer

    we offer good marijuana indica and sativa to patients who are willing to feel better and do their day to day job again.For more details text or call (425) 835-3408 or email juniorspencer10@gmail.com

  • needthatbud

    Anyone in New jersey or New York selling some danks message me or email me at needthatbud@outlook.com or text me at 1973-679-4695….

  • uuberdude

    Specialized pharmaceutical products will have their place. There is concern, however, that government and business interests want to be rid of home growing. Elected toadys who serve the corporatiban of plutocratistan are at work to that away. Home growers are competion, something that no business wants around.

  • greenbudz

    This is Great! I’m glad the FDA has approved this medication and hopefully this WILL encourage the Feds to look into the possibility that marijuana can be used as medicine.

  • Jack

    Since there has never been a fatal drug overdose with Marijuana, my only thought is that the parmaceutical people will make a dose that could kill! Keep it simple and let those grow it or purchase it via a simple, yet easy interface with the farmers or whatever. I’m sure the Drug Companies can make an effective pill!

    Jack

  • Kushington Budz III

    Join the campaign to abolish garbage weed The No MiD movement,.. IG kushingtonbudziii

  • painkills2

    “A lie can travel half way around the world while the truth is putting on its shoes.” Charles Spurgeon, brainyquote