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Julie  Stachowiak, Ph.D.

Sativex Makes Progress Worldwide, Including in US

By April 26, 2011

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Sativex is a drug that contains two main compounds derived from marijuana, the cannabinoids cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC). It controls involuntary muscle movements in people with multiple sclerosis (MS). It also has been shown to help with MS-related pain, spasticity and bladder dysfunction. It is sprayed into the mouth.

Sativex is currently in a Phase III trial in the US for treatment of cancer pain, which is a necessary step for receiving FDA approval.† Once FDA approval is received for Sativex, it can be used off-label to help people with MS. (For more information on how this works, read What is "off-label" use of drugs and is it legal?)

Sativex is currently approved in the UK, Spain, Czech Republic, Canada and New Zealand as a treatment of multiple sclerosis spasticity.

The US license to Sativex is held by Otsuka Pharmaceutical Co. Ltd in the United States and to Bayer HealthCare AG in the UK and Canada. GW Pharmaceuticals has signed a deal to have Novartis (makers of Gilenya) market Sativex in parts of Asia, the Middle East, Australia, New Zealand and Africa, so is moving ahead in those markets.

Comments
April 26, 2011 at 5:19 pm
(1) Scott says:

how long do drugs stay in phase 3? would this only be available in states that have medical marijuana programs??

September 6, 2011 at 11:41 pm
(2) Andy says:

Stage three clinical trials can vary since they are looking for longer term side effects but often last about 6 months. Sometimes there are two periods in stage 3, a and b. Sativex is in stage IIIb in the US.

It will be available from any doctor that wants to prescribe it. It’s just another prescription drug.

April 27, 2011 at 11:52 am
(3) Renee says:

I echo the previous person’s first question. How long does a drug stay at Stage 3? My state has passed a medical marijuana bill. What would be the cost of it?

April 29, 2011 at 2:35 am
(4) DL says:

I don’t know why you would want it, after all, it is just liquid MJ and it is very expensive. Keep accessing the real stuff and make your own. It is cheaper and works just as well.

April 27, 2011 at 5:29 pm
(5) Shaunee says:

This sounds like a drug I could really use since I have issues with getting shakey and mouth tremors at the same time medical marijuana is hard to get in my state.

April 27, 2011 at 6:40 pm
(6) sara mccloskey says:

if you get a dr to write a prescribtion can you get this in Canada?

May 16, 2011 at 9:27 am
(7) An ARNP in Washington says:

Sativex is available in Canada, and specifically approved for MS. I don’t live in Canada, but you shouldn’t have trouble finding someone to write this for you.

May 4, 2011 at 5:00 pm
(8) Marc Bhend says:

Over the years I spent at least $100,000 on different medications for the treatment of my MS.
- I pricked myself with Avonex for two years to no avail.
-Then my neurologist (a professor of neurology at the U of Washington) recommended Rebif. I pricked myself for anothe two years. It didn’t do anything for me, except lighten my wallet.
-Then my neurologist put me on Copaxone for two more years. Again, no improvements whatsoever.
-Then the neurologist experimented with another treatment for two more years: Novantrone. Again, not even the slightest improvement.

A friend of mine suggested that I’d see a neurologist at the
MAO CLINIC. The good doctor, there, didn’t beat around the bush. After patiently listening to my story, he said: “All the money you spent over the years supported only the Pharmaceutical companies but their medications could not possibly have helped you with your Slowly Progressive MS. There is absolutely nothing that has been developed to cure your type of MS. My recommendation is that you continue taking the lowest doses of Tegretol. Enjoy the rest of your life the best you can. There is nothing we can do for you.

As I developed Trigeminal Neuralgia over the yrs. which became very painful, the only drug that could control the pain was Tegretol. When the pain intensified and could no longer be controlled with Tegretol, another neurologist in Seattle suggested an ominous sounding treatment: Gamma Knife Surgery! The surgery was noninvasive and involved shooting gamma rays into my brain, actually frying the surface of the main nerve in the brain creating, sort of, a callous on its surface to render it numb when it comes in contact with a large blood vessel nearby. It worked! I’ve had no trigeminal attacks for the past five years. Although I still take 600 mg. of Tegretol per day, I’ve experienced no more trigeminal pain.

I keep my fingers crossed.

Marc

May 12, 2011 at 12:50 pm
(9) misty says:

i dont understand how this is supposed to be better than the real thing, granted this drug has its place esp for some who have breathing problms, but taking the main 2 chemicals and making them available for perscriptions completely negates the arguement that marijuana is a dangerous drug. the main chemical compounds Are Good Medicine but the entire natural plant is Great Medicine created by God for us, not some freak accident of nature. The evidence is overwhelming for me as an MS patient. i have pain spasticity occasionaly severe bladder disruptions and worst of all the feeling of suffocation due to the poorly named “MS Hug.” Id try sativex if i could afford it and my nuero wrote me an RX but i dont think it can replace smoking for medical reasons.

May 15, 2011 at 12:49 am
(10) Taylor says:

Its ridiculous that they can patent a DRUG derived from a natural plant!. its not just THC and Cannnabidiols that do the job, there are so many more smaller but equally significant cannabinoids bundled up in Cannabis that give it the almost heavenly powers that have been chased by scientists for years!!

May 16, 2011 at 9:24 am
(11) An ARNP in Washington says:

From what I know about Sativex, it actually does contain many of the valuable cannabinoid and other products that are present in whole-plant marijuana. I agree that it is not just the THC and a few cannabidiols that do the job, but Sativex seems to be the first drug on the market that has some promise in maybe having captured more than just synthetics (such as Marinol which is basically a poorly-tolerated and largely unhelpful drug). They actually take whole plant cannabis and extract everything out, and make an oral tincture, much like you would buy at a dispensary, but in a controlled dose. This is very helpful as a clinician, because we can feel we are writing for a known dose, since this has been a big fear to many (although personally I feel confident in my patients’ ability to self-titrate with whole-plant cannabis). Smoking marijuana is an unhealthy way to consume the plant and many find vaporizers cost-prohibitive, or providers don’t know to recommend them, so healthcare has a way to go in dealing with this helpful medication (both in the new pharmaceuticals and in whole-plant) and finding the best way to physically get it into patients’ bodies.

November 19, 2011 at 7:30 pm
(12) What says:

Man, I mean spending too much money to big pharma for a spray version of THC. What a joke.

They sell 50 dose tincture which contains CBC and THC for about 10 bucks at dispensaries.

They also sell a huge selection of edibles, including chocolate, beverages, Pre-made meals (frozen pizza, etc), baked goods (cookies, brownies, rice crispies, etc) that ll contain medium-medium high doses which are perfect for pain symptoms.

The fact that its pretty much a tincture in spray form that is 100% legal that you can only buy from big pharma is a huge joke. It probably will also taste like “medical cherry” flavor to prevent “unlawful” uses is also a negative.

June 28, 2011 at 9:31 am
(13) Jessica says:

Can anyone tell me how long drugs usually stay in phase III trials? In other words, can anyone give an estimate roughly of when Sativex will be avail. in the US? I mean are we talking the year 2012, 2015, 2018, 2194?

September 11, 2011 at 11:25 pm
(14) Jo says:

Funny how vioxx never took this long to go through and ruined my skin for life, not to mention caused me to now be allergic to other medicines, such as the one that damaged my pancreas, for life, and now over night ended up with insulin dependent juvinile diabetes (which has nothing to do with diet, weight, nor genetics) and get to face seizures, coma’s and the possibility of death everytime I lie down to sleep.

I started begging my congress to help way before my body was damaged, and continued after, to no avail, they didn’t and don’t care that the FDA quickly approved medicine that weakened my heart, damaged my brain, pancreas, and basically my whole body, and killed others even quicker than they are killing me and is taking years to approve a natural medicine that actually heals, while medicating, and has caused no death. Jerks!

October 12, 2011 at 3:32 pm
(15) steve collier says:

Hi Jo,yes we have the same jerks in the UK…mhra and NICE…my mother would have been in so much less pain if these idiots would engage their brains for once..instead she suffered in agony until they put her under the scapel and injected stuff into her spine like a human guinea pig…she got MSRA and sadly never recovered…a needless suffering and death because of beaurocratic dinosaurs!

December 2, 2011 at 9:54 pm
(16) Vel says:

Watching a National Geo Special called “Marijuana Gold Rush” and just now learning of Sativex. Considering I live in the US and in a “Bible belt state” that doesn’t allow medicinal use of Marijuana I suppose it is pointless to get my hopes up on when it would be available or its’ efficacy? Thus, I shall continue to consume the legal Oxy, Hydrocodone, Ativan and Baclofen that now do nothing for me after all these years but keep me from suffering withdrawal…well that and destroying my liver. Lovely. I also enjoy the occasional relief I obtain from the Marijuana I get from illegal sources. I want to thank my state and Country for making it possible for me to risk my health and freedom when all I want is just a little relief.

February 3, 2012 at 8:24 pm
(17) Ben says:

I have M S and live outside the U S. My M S specialist has perscried Sativex on a 6 month trial basis. I am presently in the program. I will be travelinjg to the U S this month. How can I get approval to bring Sativex to the U S? Thank You.

April 7, 2012 at 8:04 pm
(18) todd says:

My Marinol 5mg costs $1,700 a month for 120 capsules and the 10mg are twice as expensive for120 capsules, so it will probably be berry expensive or around the same !! I can’t wait for USA to approve the medicine I need and many many many others need!!!!!!

September 17, 2012 at 4:08 pm
(19) James Threadgill says:

The Irony of My Situation

I suffer neuropathic pain from TMD-tendonitis of the temporalis. It is an excruciating condition but non-life threatening. I have to submit drug UA tests regularly and while it is okay for me to be positive for benzodiazepines and opiates, if I’m positive for cannabis–which provides the most effective relief and is far safer, then Iím a drug abuser.

I am forced by my situation to play Russian roulette with dangerous narcotics, which are doubly perilous for me as an alcoholic who hasnít had a drink it more than 20 years. The narcotics scare me so I only take them when itís very bad and then I break them in half. If I havenít gotten relief in 2 hours, I take the other half in order to sleep.

You should all try that shoe on for size!

September 21, 2012 at 7:10 am
(20) Shara says:

Marinol isn’t poorly tolerated nor ineffective, but it was never designed to releive pain or spasticity. Marinol is highly effective at stopping naseau and increasing appetite. I’ve been taking it for months now, and have noticed no side effects. Real marijuana is however, more effective.

February 17, 2013 at 10:40 pm
(21) KPow says:

I also have chronic back pain and have been in pain management for over 12 years.Then 3 years ago I had a Doctor that was smoking crack in his back office and he was percribing me leatal doses for over 2 years and when l finally relized that there was no way for my body to assimilate that many drugs l asked him to reduce the dosage a he would not. l left his office and had to go to a methadone clinic because l could not find a doctor that would help me slowly reduce my daily dosage. This medicine gave me terrible digestive problems, so bad that even now l am still healing.
i had a chance to try staviex and it worked, not only for my leg spasms but l was also experiencing sever leg pain and back pain. Unable to find a legal outlet to obtain this wonderful medicine l am forced to keep taking this poison ‘Oxy’,and l am unable to stop taking it unless l can switch to an extract like Hash Oil. If anyone knows the best way to get it legally or how we can help make it legal please let us know. lt hard to believe we as Americans have let the government and other entities to keep us from a medicine that works and that is non addictive.

February 21, 2013 at 11:23 am
(22) John says:

I have CMT which is very similar to MS. I live in NY. Is there any way that I can be prescribed Sativex or possibly get in on a testing study to help treat my symptoms? I live near Buffalo NY, Canada is a mere 20 minute drive. (If I lived in Canada I wouldn’t have this issue) FRUSTRATING!!!

April 23, 2013 at 7:09 pm
(23) Wayne says:

I’m a cancer survivor of 7 years, with severe chronic pain. As a current patient, with a valid & active prescription for Sativex, I can tell you absolutely that all of the nay-saying about Sativex is a bunch of Hooey! The only thing missing using this vs. smoking it is the coughing of all those partaking, and the smell. It (Sativex) works EXACTLY the same way. It’s not as quick as smoking, but MUCH more convenient to use.

In my mind, the most important consideration here is that IT WORKS. It reduces pain, and it reduces the number and severity of muscle spasms. For once, being a Canadian is a HUGE benefit. Right now, my biggest concern is whether or not I can legally bring it into the U.S. when I’m there on business. Time will tell..

August 1, 2013 at 2:02 pm
(24) bb says:

My understanding is that this company isolated particular components from the plant – much like taxol is derived from the yew plant (a cancer drug). Sativa is not the same as whatever you get when you smoke or eat pot – that is a complex mixture of a number of chemicals, each of which probably has multiple effects. That’s not what you want from a drug. If you enjoy the high from pot, then I suppose buying such a drug doesn’t make sense. But if you have a disease with symptoms that can be treated specifically with these isolated plant components and do not want the high, it makes much more sense to take the drug. I for one do not at all enjoy the effects of pot and wouldn’t smoke it to treat any disease related symptom. Take away the psychoactive effects as they have done in Sativa, and I am all for taking a drug that has been tested and taken through clinical trials for a specific symptom or illness. Plus, you have a better chance of few side effects since this is a well studied and used plant in human history. Compare to some other pharmaceuticals out there with dangerous side effects, and this option seems like a safe and helpful drug. BTW, I wouldn’t consider a little company like GW “big pharma.” Sounds like a little company with a good idea.

December 2, 2013 at 7:19 pm
(25) Mike M says:

I’ve had RRMS for five years. I work at a Credit Union. We just merged with another Credit Union and they drug test. I have had to stop smoking MJ that God gave us….it really helped BTW. My question is if I have a prescription for Sativex (once or if it is approved in the US), can they tell the difference between the smoked MJ and the Sativex in the urinalysis??? Can anybody help me with that question?

January 21, 2014 at 8:12 pm
(26) Frank says:

@Mike M

The answer is no, unless they do a very expensive test that doesn’t check for just THC. I’m on Marinol and use the real thing because it works and Marinol is garbage.

February 16, 2014 at 3:29 am
(27) Michael Mueschgambino says:

How long will this-take?-I-smoke-marijuana-for-panic-disorder,-adhd,-muscle-spasms-and-for-insomnia-as-well-as-to-eat.-i-can-no-longer-afford-marijuana-as-i-am-unable-to-work-due-to-these-issues-as-well-as-no-money-to-receive-marijuana-to-re-start-pursue-employment.

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