June 21st, 2010
02:15 PM ET

World's first fully approved cannabis drug on sale in UK

By Elizabeth Landau
CNN.com Health Writer/Producer

A medication called Sativex has become the first drug fully approved for multiple sclerosis that is made from natural cannabis.

The United Kingdom's Medicines and Healthcare products Regulatory Agency approved the drug, an oral spray, on Friday, and it went on sale in the country on Monday. The drug has been available in Canada on a limited basis since 2005 for the relief of neuropathic pain and advanced cancer pain, and also to a small number of patients in Spain. It is expected to be approved more broadly in Spain later this year.

Sativex is approved by prescription only for multiple sclerosis patients in the U.K. It targets the effects of spasticity, a symptom of multiple sclerosis caused by damage to nerves in the central nervous system. Loss of mobility and painful spasms may result from this involuntary stiffening of muscles.

The drug is sprayed into the mouth on the inside of the cheek or under the tongue, said Bayer Schering Pharma, the pharmaceutical company launching the product. Cannabis plants grown in a controlled environment give rise to the extracts that are the active ingredients of the drug.

The Multiple Sclerosis Trust, a U.K. charity, supported the launch of this medication.

In clinical trials, only about half of study participants with multiple sclerosis found that it relieved spasms and cramping associated with spasticity. For this sort of research, that's a good result, said Mark Rogerson, spokesman for GW Pharmaceuticals, which developed the drug.

There is no evidence of long-term dependence or tolerance; patients have not reported needing to take more of the spray, and many say they've reduced the dose over time, Rogerson said. Common side effects include dizziness and fatigue.

The cost is 125 British pounds for a pack of the spray,  or about $185, which works out to 11 pounds per day, or about $16, for the average patient, Rogerson said.

In the United States, the only medical marijuana treatment available is a prescription drug called Marinol, whose active ingredient is synthetic THC - making it distinct from the natural cannabis plant extracts in Sativex. In the U.S., cancer patients may take Marinol to relieve nausea and vomiting side effects of chemotherapy, and AIDS patients may use it to help with loss of appetite, according to the U.S. Drug Enforcement Agency. Marinol comes in the form of a pill, although other delivery methods such as inhaler or patch, are being explored.

Sativex is in phase II clinical trials for cancer patients in the U.S., Rogerson said. He estimated that it will be about two years before it could get U.S. Food and Drug Administration approval.

Rogerson noted a difference in the political climate surrounding medical marijuana in the two nations.

"U.K. public opinion is quite ready for a cannabis-based medicine. There’s really very little sense of, 'Oh gosh it’s cannibis, it’s a bad thing,'" he said. "People understand that it’s different from recreational drug-taking, and also that it’s a treatment for a number of people who suffer from a very, very debilitating illness."

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soundoff (190 Responses)
  1. Tom

    Side effects include fatigue, LOL. Well duh! I'm surprised they didn't mention the munchees and laughing as side effects too.

    June 21, 2010 at 14:52 | Report abuse | Reply
  2. RodRoderick

    As much as I'm all for moving forward, however small the step, toward complete legalization I have to be completely honest in saying Marijuana is not a pain killer. It is a relaxant. It's good for meditation but not killing pain. It's too bad that we have to take this step to get people legally taken the plant in order to show that all the lies that were generated back in the 30's to force this ban are completly false.

    June 21, 2010 at 15:02 | Report abuse | Reply
  3. bailoutsos

    I have read that even if you are using a drug like this and your company does drug screening, you may get fired even though it is a prescription.

    June 21, 2010 at 15:10 | Report abuse | Reply
  4. Debbie from Naperville, IL

    I suffer from painful spasms due to multiple sclerosis. My state has a medical cannabis law stalled in the Legislature due to opposition from police and conservatives.
    Many people are uninformed about the relief that cannabis gives to the chronically ill; they still believe it is a gateway drug to other hard drugs for youth, when in fact the parents' medicine cabinet is the beginning of many teens' drug use.
    I have never tried cannabis, but if this bill is not passed into law soon I will be forced to break the law, because the pain is occasionally unbearable and I am afraid to try pain killers, due to the possibility of becoming addicted. Marinol does not work for the type of pain I experience, so I am hoping and praying that our state government gets serious about helping the chronically ill.

    June 21, 2010 at 15:10 | Report abuse | Reply
  5. End the War

    Whether it's medicinal or recreational, shouldn't matter. It helps people, and it does very little harm when compared against the commonly abused alcohol and tobacco. Let's stop the War on our own people.

    June 21, 2010 at 15:17 | Report abuse | Reply
  6. Mike

    Legalize and Tax it in the United States already. MJ is harmless while alcohol and cigarettes continue to kill thousands each year.

    June 21, 2010 at 15:28 | Report abuse | Reply
  7. michael Pantaleon

    In the Asian countries,as Sri Lanka,India,had their own Aurweda treatments which are derived from plants and its components to treat for different ailments of mankind.As the countries was taken over by British Colonials,they knew the traditional treatments done by Aurvedic doctors and noted that canabis is used for some of the treatments,and they knew it is taken as a smoke too to get a little kick,and could eat well.Hence they banned this and stopped cultivations,and fined the cultivators.Now they are introducing canabis in the form of western therepy,whereas it was there in Asian countries before westerners were civilised.India and Sri Lanka has a long history and civilization before westerners,had their own medicines for any type of treatment and even for broken limbs,legs etc.So it's no wander to make drugs out of canabis, as Aurweda knows the value of this plant before scientific reserch was done.

    June 21, 2010 at 15:35 | Report abuse | Reply
  8. sk8104s8tan

    you know, marijuana can be made into food (cookies, brownies, cakes), or mixed with butter for a pesto sauce on pasta etc...there's so many ways it can be used, not only smoked. giving patients an extract from the plant in a chemical spray form is good for some but should not be limited to that. if a patient chooses to smoke or eat medicinal marijuana nobody should tell them otherwise, everything if used properly can be beneficial medicinally or even just for that state of well being in an otherwise hopeless existance.

    June 21, 2010 at 15:37 | Report abuse | Reply
  9. J~Go

    I am a professional who also suffers from MS. I take an interferon injection every-other day and occasionally use a non-prescribed herbal remedy to mitigate some of the medicine's side effects. I can 't wait for the day that I can purchase a legal form of relief.

    June 21, 2010 at 15:58 | Report abuse | Reply
  10. Neil

    Its only a plant, it just happens if you light it up and inhale the fumes there are some side effects 😀

    June 21, 2010 at 16:02 | Report abuse | Reply
  11. Andrew

    For those who don't know marijuana does relieve pain, I'm living proof. So, sometimes I'm a bit tired which bothers me occasionally but the alternative leaves me with the feeling that I'd rather not wake up in the mornings. If you don't know what real pain is you cannot comment.

    June 21, 2010 at 16:09 | Report abuse | Reply
  12. Semantics

    Yeah.. before it becomes legal pharmaceutical companies will do everything in their power to stop it. Instead they will make a "safe" drug that they'll sell instead, so they can continue to make billions of dollars with legal drug dealing.

    Funny, that a PLANT can be illegal. Aren't we a religious people? Are we really criminalizing possession of a plant that supposedly "God" made?

    Personally, I don't believe in god, but I do find it funny that people can be so hypocritical.

    June 21, 2010 at 16:14 | Report abuse | Reply
  13. Spendlove

    Lame, just make it legal.

    June 21, 2010 at 16:20 | Report abuse | Reply
  14. John

    Those supporting medical marijuana tend to be their own worst enemies as they try and paint it as a wonder drug for just about everything so people who might be swayed are hesitant to support it.

    Does it have some benificial effects in limited circumstances? Yes I believe it does, but I don't expect attitudes about it to change until those who support it for legitimate medical use distance themselves from those who simply push medical marijuana so as to allow easier access or as a step toward legalization.

    June 21, 2010 at 16:35 | Report abuse | Reply
  15. Jan Michael

    Canada has had Sativex and I, as a person with PPMS have taken a single spray nightly, relieving MS pain and giving me a quality sleep. Occasionally I need it in daytime but Sativex, sublingual spray does not make one "high". It is for Neuropathic pain and the MS pain of feeling my body is on fire is and has been solved since I started Sativex, Sold in Canada by owners Bayer who bought the rights from GW pharma.

    Those who do not think this cannaboid under the tongue spray works on pain need to ask us with Primary Progressibe MS and Cancer patients. It is not like smoking "weed!" It is covered by my Insurance plan and the pressriprion is filled at the pharmacy just like any prescription. Cost is $175. Canadian and a bottle has 48 sprays , best kept in fridge,

    It has been a life saviour or at least a marriage saviour for me as I do not want to smoke anyhing and do not like a high from Marijuana or liquor.. I just was in so much pain and for last 3 years with Sativex life is better!!!

    Glad UK has joined Canada and Spain since it was developed in UK and now with MS prevalent ib North Europe and Canada it is relieved, T hank you GW, Bayer, Canadian Health and my insurer.

    June 21, 2010 at 16:47 | Report abuse | Reply
  16. Jan Michael

    For the writer with MS spasm, I wish to add my leg cramps with Sativex and Baclofen anti-spasmotic were 90% gone. The Sativex was supplementing the insufficient Baclofen and I think the relaxation effect of Sativex was what let the usual Baclofen work better.

    NARCOMs North American Registered Consortium on MS
    (Yale University study) is something worth checking as they send surveys and look for MSwes as participants..

    June 21, 2010 at 16:59 | Report abuse | Reply
  17. Sean

    One has to wonder why marijuana is still illegal.
    Clearly it has minimal negative side effects when compared to legal products such as alcohol, cigarettes and even all the herbal packs and energy drinks sold with out age restrictions.
    Who benefits from marijuana being illegal?
    Law enforcement and pharmaceutical companies are the clear beneficiaries.
    I was hoping to see New Jersey step up with the new medical laws but they seem to be backtracking now.
    I believe future generations will look back at this the way we look back at the prohibition of alcohol.

    June 21, 2010 at 17:13 | Report abuse | Reply
  18. Ken Sherman

    This is a very benign drug. Zero deaths per year due to toxicity. It's safer than virtually every over the counter drug on the market including aspirin, much less prescription drugs. One cannot overdose.

    Why do we need PERMISSION from a government to use this plant? For any reason? God gave it to all of us. Governments should not have the right to refuse its citizens the use of a plant!

    It also has 10s of thousands of uses as fuel, food, building materials.

    June 21, 2010 at 17:21 | Report abuse | Reply
    • Mary

      I thoroughly agree with you. I'm 71 years old and the perscription meds that I take are killing the organs in my body. They also gave me a heart attack. They killed my sister with so many legal perscription drugs her body just gave up. The side effects from them are horrendous. There is not one bad thing about Marijuana, other than you may laugh yourself to death. I think I would rather die laughing than by loosing an organ a month from the poison they give you to cure what ails you. I don't think anyone should tell you, you can't smoke a harmless plant if you want to. These liars that try to scare you by saying its bad for you are just that, liars. Take the drunks off the road if you want to do something constructive. That will save more peoples lives and families than anything pot smokers.

      August 31, 2010 at 06:58 | Report abuse |
  19. liam

    It's a crime that this small step has taken this long. An absolute crime.

    June 21, 2010 at 17:29 | Report abuse | Reply
  20. Mark R. Phelps

    The only reason natural plants are illegal is so corporations can create these drugs and make a profit. Why is the cost of health care so high? Because government controls that do not allow us to use age old treatments and make our own medical decisions.

    Prohibition was never about the public good, but about money, power and control.

    June 21, 2010 at 17:34 | Report abuse | Reply
  21. Nurse Lisa

    Marijuana can be psychologically addicting – so the person afraid to try other FDA approved pain meds despite yrs of documentation regarding long-term safety and manageable side effects in favor of a very new med with unproven safety or efficacy and potential for addiction over long-term use, doesn't make sense to me.

    That being said, there could be much to be said for the financial benefit of curtailing drug crimes if we legalize use, the ability to standardize potency and if we tax the heck out of it to pay for the many potential complications of use down the road.

    June 21, 2010 at 17:42 | Report abuse | Reply
  22. Anth

    this stuff was done years back and proved ineffective, now they re-issuing the same junk, different day, new name, etc, new campaign it's BS. But only in england, man, that placed messed up seriously 😀

    June 21, 2010 at 17:43 | Report abuse | Reply
  23. maria

    Marijuana is NOT BENIGN as some of you think. As a doctor, I've seen pts on it and read studies of its effects. It does cause brain cells to die, and in effect can cause problems with impulse control and judgement, memory, slowed reactions even personality changes like schizophrenia. Smoking marijuana has the same effects as cigarette smoking such as emphysema, heart disease, and cancer. Because of impaired judgement and slowed reactions, a person under the influence of marjijuana can get into an accident and kill someone and/or themself.

    June 21, 2010 at 18:06 | Report abuse | Reply
    • Mary

      How would you know ? Have you ever smoked it ? Talk about driving and killing, have you counted the deaths from drunk drivers lately ? Wheres the fight against that ? I don't recall reading about a bunch of deaths from pot smokers lately. I'm sorry but I know to many people that do partake and I can assure you they never act anything but normal. They all have normal jobs and some of them are doctors and nurses and policeman.

      August 31, 2010 at 07:09 | Report abuse |
  24. Adam

    That's great news. Of course, Marinol was created to make a synthetic form of something that could be derived from a plant. This way, the drug can be controlled by the pharma company.

    June 21, 2010 at 18:43 | Report abuse | Reply
  25. Ronnie Harper

    Why is a plant illegal? Because conservatives would rather big pharmaceutical make even more billions every year than let regular people make decisions regarding their own liberty and health. It's always the same answer in the U.S. – white, wealthy conservatives want the cake they already have, and to eat all the other cakes, as well. They blind their constituents with religion and then laugh at them while they break their own rules.

    June 21, 2010 at 18:57 | Report abuse | Reply
  26. jamjag

    I live in IL also, and the stalling of the bill in the legislature is infuriating. I suffer from Rheumatoid Arthritis, and the pain is constant. While marijuana doesn't kill the pain, it does take the edge off it while still allowing me to work and function in everyday life. Current prescription painkillers make me so loopy and out of it I can't function.

    Other states (not counting CA) have implemented a medical use law and aren't having problems with it. I wish IL would get on board and stop making sick people criminals because they have no other recourse.

    June 21, 2010 at 19:08 | Report abuse | Reply
  27. jphilly08

    I hope this drug does not get approved because it could be touted by critics of MJ regulation as a medical alternative to smoking "medical" MJ. In other words attempt to keep the plant illegal and only legalize the spray.

    June 21, 2010 at 19:35 | Report abuse | Reply
  28. Angela Sather

    Trust me ...if you are in desperate pain or dealing with the debilitating effects of MS, this may show promise while helping people on a more natural regime, rather than being pumped up with lots of drugs that are popularized by major drug companies in it for the BIG MONEY....

    June 21, 2010 at 20:18 | Report abuse | Reply
  29. Lady Mithra

    Another way for the pharmaceutical companies to make an outlandish amount of money. Generally, things that are processed are not good. This is a natural remedy. Legalize marijuana, it was legal in the past and taxed. Ask any stamp collector, they can probably show you a marijuana tax stamp. My husband tried Marinol when he was dying, it did nothing for him. The government needs to stop looking at this herb as a "gateway drug" and look at the real culprits–cigarettes, alcohol and all those prescription pills that they make so much money on that they later find out are addictive.

    June 21, 2010 at 20:43 | Report abuse | Reply
  30. Jen H

    We have a drug called Marinol which is synthetic THC which could be used and have the same effect. I have used it in treating Alzheimers patients to increase relaxation lower aggression and bump up their appetite.

    June 21, 2010 at 21:13 | Report abuse | Reply
  31. chris

    Legalize and TAX it. We will all be saying 'why didn't we do that earlier!'

    June 21, 2010 at 21:13 | Report abuse | Reply
  32. lance corporal

    I (and many many MANY others) will continue to spend money on marijuana, some of this money will go to organized crime, I know that, even tho I frequently get my supply from local growers I can't always, and as these criminals get more money they branch out and create more crime. ANY one who has ever looked at the "drug war" knows this including top law enforcement, prohibition doesn't work, that is also a known, it is just bizzarro to me that we keep doing the same thing over and over again that HASN'T worked and we know will NOT. I don't drink alcohol, not a drop, don't smoke cigs, I work, I'm fit, I'm a good parent, I'm not addicted to anything and I only smoke at appropriate times and ya know what, I'm the average pot smoker, you right wing radical fear mongers are just functionally stupid

    June 21, 2010 at 21:17 | Report abuse | Reply
  33. Mike Green

    I think we should legalize marijuana so our youth can have another problem to deal with. Sure some could get it illegally but two wrongs don't make a right. To think this would benefit society with no negative adverse affects, you must be high. I can just see kids showing up to school baked......future assistant managers of french fries at McDonalds.

    June 21, 2010 at 21:18 | Report abuse | Reply
  34. jms

    In the absence of over the counter medications, pot works as a pain reliever and muscle relaxer. It also stimulates the appetite of older people who do not eat enough.

    June 21, 2010 at 21:21 | Report abuse | Reply
  35. Yoda

    @RodRoderick: I wholeheartedly disagree that cannabis is "not a painkiller." It isn't an opioid, and I'd still rather have a big shot of morphine after orthopedic surgery than several hits of marijuana. But, I speak from experience–it works quite well to take the edge off moderate to severe pain. It's great especially in conjunction with opioid painkillers. In fact, my pain specialist said soon we will see prescription drugs that combine the two because they compliment each other so well.

    June 21, 2010 at 21:33 | Report abuse | Reply
  36. Gkygrl - Diana

    All the more reason to legislate the usage of medicinal cannabis and bring this medication to the US. It works for MS and we need this now.

    June 21, 2010 at 21:36 | Report abuse | Reply
  37. Fred

    Hey there, I laugh at the hypocrisy created over a small plant. It is illegal to consume recreationally, but announced as its chemical derivative. People don't need to buy this medicine to get the affects of cannabis, Smoking it has proved to be much faster at relieving spasms/neuropathy commonly associated with MS. Please re-legalize this plant so all can share its benefits,whether medicinally or recreationally. I would say, Any Cannabis use in ANY way should be medical. I use it to meditate, How is that different from using it to get high? Everybody uses it for their own personal reason, and more power to them. No one but GOD has the right to tell you what you can put into your OWN body. --Fred Flinstoned.

    June 21, 2010 at 22:24 | Report abuse | Reply
  38. Red45

    With a lifetime of pain from the age of 3 (hereditary migraine + several neck and back injuries that never totally healed), medical doctors have had only one remedy for me: pain killers–addictive narcotic drugs. That's it. So, after a multi-year struggle with trying to balance Rx pain killers, single parenthood and a demanding career in technology, I got off them for good and turned to OTC painkillers. Eleven years later, I was diagnosed with OTC painkiller poisoning and had to get off them and heal my body. Now, the strongest medicine I use is medical marijuana that has none of the side effects of all those narcotic and OTC drugs. I also have chronic insomnia and it works for that as well.

    When we legalize marijuana in California in November, the State will begin to reap billions of dollars in taxes on it-just exactly the way liquor and tobacco sales are handled in CA: sales to adults only and taxed to the hilt. The only difference being that alcohol and tobacco are narcotics and marijuana isn’t.

    June 21, 2010 at 22:32 | Report abuse | Reply
  39. jimbo

    So a drug company comes up with a cannabis extract that costs only 16 bucks a day. I am grateful the company has brought relief to those suffering. My question is this – did they try testing all the patients with regular unprocessed marijuana just to see if it worked better than the man made elixir.

    June 21, 2010 at 22:52 | Report abuse | Reply
  40. Fred Flintstone

    So let's get this straight: they grow perfectly good weed, then they distill it down into some sort of spray. And this is done by some kind of patented process owned by a big drug company. Wouldn't it make more sense to allow people who want to use cannabis to just grow it themselves, or if they don't want to grow it, purchase it at the store? I mean why do big drug companies have to get involved? Cut out the middlemen.

    June 21, 2010 at 23:00 | Report abuse | Reply
  41. Rich McCrea

    What about dronabinol? It's been a medicine for a long time and is THC.

    June 21, 2010 at 23:03 | Report abuse | Reply
  42. Jeremy

    *read this* Is anybody surprised a drug company is profiting off marijuana and the UK and US FDA are on board to make this legal? I mean come on, marijuana grows in the dirt and should be free for anyone who chooses to partake. How can you justify this drug but natural marijuana that's been consumed by humans for thousands of years remains illegal? This is an obvious no brainer..prohibiton does not work, they figured that out in the 30's... Time to take back our borders, free up our prison system and start using common sense to get this country back on track!

    June 21, 2010 at 23:06 | Report abuse | Reply
  43. Painsufferer

    If you think Pot can't relieve pain your full of yourself. I am 29 and smoked pot for fun for years. At 25 i got very ill, with nerve disease. When i'm in pain I have pills and I have weed. Guess what they both work. I smoke pot and then I go to the gym for 2 hours and lift weights. They endorphin release carries me for the day, the pot got me thru the workout. Don't tell people what pot does until you smoke it for a length of time and frequency which validate you opinion. Aside from pot I use Lyrica and say nice work Pfizer. Works better with pot.

    June 21, 2010 at 23:08 | Report abuse | Reply
  44. Robrob

    "The only reason natural plants are illegal is so corporations can create these drugs and make a profit. "

    Yes, that of *course* is th eonly reason why Cocaine and Heroin are illegal...

    June 21, 2010 at 23:09 | Report abuse | Reply
  45. SJB

    And don't forget–14 states have Medical Marijuana laws on the books.

    June 21, 2010 at 23:21 | Report abuse | Reply
  46. Louise

    Many 'legal' drugs are far more addictive and toxic that pot. When you are sick, in chronic pain, not sleeping, and/ or miserable, you have a God given right to natural substances that bring you relief. It is a far higher ethical principle to uphold your right than to adhere to some inane medieval law.

    June 21, 2010 at 23:25 | Report abuse | Reply
  47. Dawn Metzger

    I have multiple sclerosis and have been out of the workforce because of it for the last 12 years. I am always eager for anything that may help symptom management and find it frustrating that medical marijuana continues to be argued against. I never enjoyed it recreationally, but if it would help my tightness and spasticity I would sure like it as an option. Based on all I have heard through the years I think it would help, but I'm not willing to break the law for relief at this point, that's not saying I'll always feel that way and it's downright irritating that an honest, law-abiding taxpyaing citizen who has an illness even needs to consider if jail time is worth symptom relief.

    June 21, 2010 at 23:27 | Report abuse | Reply
  48. Rene

    For people who worry about the safety of such a medication, let me put if like this: More people die every month from aspirin overdose than have ever died from Marijuana overdose. More people die every month from Tylenol overdose than have ever died from Marijuana overdose. In fact, there has never been a documented case of marijuana overdose.

    June 21, 2010 at 23:32 | Report abuse | Reply
  49. Sad

    Whats rediculous is how marijuana is still a schedule I drug under federal laws in the U.S. meaning it has NO medical use at all. But there are people around the world using it for medicinal use and now they have even more drugs made from the plant which disputes a schedule I drug.

    June 22, 2010 at 00:11 | Report abuse | Reply
  50. Ry

    If the medical companies can formulate a spray or a pill that harnesses the medical attributes of marijuana, I am all for it. In my view, this is better option than selling actual maijuana. This country has a serious problem with illegal drug consumption. I would hate to give the nation's children another reason to beleive that pot in safe to use. I realize that maijuana is probably a safer drug than alcohol. That however, that is not saying much. Just look at the health problems, crimes, accidents and misery that can be directly linked alcohol. I just do not think our society need another legal substance to get intoxicated on. We have enough problems without it.

    June 22, 2010 at 00:17 | Report abuse | Reply
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