by Seshata on 19/12/2013 | Medicinal

Sativex Now Available Throughout Europe as Opposition to Medical Cannabis Diminishes

News Sativex by GW Pharmaceuticals is the first cannabis-based medicine to be fully approved and brought to market in any country, and is now available in 22 countries worldwide. Its steady march through Europe has been accompanied by considerable media attention, and numerous challenges have been faced and overcome.


Sativex by GW Pharmaceuticals is the first cannabis-based medicine to be fully approved and brought to market in any country, and is now available in 22 countries worldwide. Its steady march through Europe has been accompanied by considerable media attention, and numerous challenges have been faced and overcome.

What is Sativex, and Who Can it Treat?

Sativex is primarily marketed as an adjunctive (add-on) treatment for muscle spasticity arising from multiple sclerosis. As well as reducing the severity of spasticity symptoms, Sativex has been shown to ameliorate neuropathy and bladder overactivity in MS sufferers.

Sativex is now available in 22 countries worldwide, with 18 of those in Europe
Sativex is now available in 22 countries worldwide, with 18 of those in Europe

While the drug was approved as an MS treatment, it is also undergoing Phase III clinical trials in the U.S. as an adjunctive analgesic for cancer-related pain, specifically in individuals that do not respond to high doses of opiates.

Although marketed under the trade name Sativex, the drug is generically known as nabiximols, and is extracted from two varieties of cannabis (the varieties used are a closely-guarded secret) using ethanol and CO2.

Sativex is an oromucosal spray (one which acts upon the oral mucous membranes) designed for sublingual application. The drug, which is essentially a tincture of cannabis oil, contains THC and CBD in almost-equivalent amounts: each spray contains a fixed dose of 2.7mg THC and 2.5mg CBD.

Getting Sativex to Market in Canada & the UK

Sativex was first approved in 2005, as an adjunctive treatment for MS-related neuropathy. The drug received a Notice of Compliance with Conditions (NOC/c) from Health Canada, the nation’s main regulatory body—cementing its place as the world’s first cannabis medicine with regulatory approval. However, NOC/c status in Canada includes the need for further trials to fully establish the efficacy of a drug—full approval would still be some years away.

In 2007, a second NOC/c was granted by Health Canada in recognition of Sativex’ potential as an adjunctive analgesic for cancer pain, and in August 2010, a full Notice of Compliance (NOC) was granted in recognition of Sativex’ clinically-proven efficacy against MS-related muscle spasticity.

By this time, the UK had beaten Canada to the honour of being the world’s first country to fully approve a cannabis medication: on June 16th 2010, the Medicines and Healthcare product Regulatory Agency (MHRA) issued a Marketing Authorisation to GW Pharmaceuticals, allowing Sativex to be made available on prescription to MS patients for the first time. Full regulatory approval in Spain followed mere weeks later, in July 2010.

The European Mutual Recognition Procedure

Since January 1998, EU Member States wishing to approve and market a new medicine that was initially authorised in another Member State must follow the mutual recognition procedure (MRP). The approval granted by the initial Member State (known as the Reference Member State—RMS) is used to support the MRP in other countries, which are known as Concerned Member States (CMS).

If a Member State has issued full national approval for the drug already, that state is named as the RMS and the evaluation process takes 90 days. Commonly, however, an identical evaluation request for an unapproved drug is made to a number of Member States; the first Member State to undergo evaluation procedures therefore becomes the RMS and the other states become CMS. In this case, a full approval and evaluation process can take up to 210 days.

Sativex is an oromucosal spray designed for siblingual application
Sativex is an oromucosal spray designed for siblingual application

After MRP approval, any new drug must complete several steps to gain full approval at a national level: first, local wording and country-specific information must be finalised, and a national marketing authorisation must be issued. Once the RMS has approved a drug, CMS have 90 days to formally recognise the decision of the RMS and to conduct the necessary locale-specific steps; a further 30 days is granted to finalise and issue a formal marketing authorisation.

Sativex & the European MRP

Following initial approval in the UK and Spain, an MRP application was swiftly made. The UK’s MHRA agreed to act as RMS; Concerned Member States comprised Germany, Denmark, Italy, the Czech Republic, Sweden and Austria. The MRP was declared successful in all states on the 22nd March, 2011.

The success of the initial submissions led to a new MRP application to allow Sativex to be licensed in ten more European countries:  Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia. On the 8th May 2012, GW announced that the MRP had been successful and that Sativex had been approved for sale in all ten countries, bringing the total in Europe to eighteen.

Worldwide Availability of Sativex

In August 2013, GW Pharmaceuticals filed a Phase III investigational new drug application with the Food & Drug Administration (FDA) to evaluate Sativex as a treatment for MS-related spasticity. Under the terms of the proposal, the evaluation program will be funded by GW’s U.S. licensing partner Otsuka Pharmaceutical; the program is likely to begin to 2014. The same year, the results of Phase III trials to establish Sativex’ efficacy as a treatment for cancer pain, commenced in November 2010, will be published.

GW Pharma is the first company to successfully market a cannabis medicine, and the first to receive UK Home Office permission to cultivate medicinal cannabis
GW Pharma is the first company to successfully market a cannabis medicine, and the first to receive UK Home Office permission to cultivate medicinal cannabis

Outside of Europe, Sativex is currently available on prescription in Canada and New Zealand, and has also been approved in Australia; in the latter case, as cannabis is listed on the National Poisons Schedule, full approval cannot occur until it is removed or reclassified.

What Next for Sativex?

Following the legalisation of cannabis medicines in France in June 2013, an MRP application was submitted in July. Given the recent approvals of Sativex in the majority of other EU states, it could be argued that the law was essentially changed in recognition of the need to accommodate it and other clinically-tested cannabis medications, such as Marinol (a synthetic form of THC).

Sativex has not yet been approved by the French regulatory body, ANSM, although an MRP application was submitted in July 2013. Applications usually take 90 days to process, so the result will be known by the end of October 2013.

Sativex is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, New Zealand and Italy; the remaining countries that have approved the drug are currently preparing to launch it. Licensing agreements have been made for many other countries, including many African and Asian nations.

In our next article on Sativex, we will take a closer look at the various criticisms and commendations that Sativex has received, from the patients, doctors and lawmakers that are directly involved in the process of bringing it to market.

Comment Section

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Andy

For whatever reasons, it is almost impossible to get a prescription in the UK from what I have heard.

19/12/2013

handytrim

Sativex, brought to you by the same country that continues the lie that cannabis has no medicinal benefits! So why allow a WHOLE cannabis tincture to be produced and sold whilst also denying the citizens (especially those that need cannabis medicine the most) of the UK access to the many times cheaper herbal alternative (such as bedrocan)? Answer. Corruption! Something that is going to be exposed in a variety of ways very soon and those that are part of this disgusting state of affairs will have to explain before a court of law.

20/12/2013

Alléesu

I agrée with the above comment.

08/01/2014

Judy Epstein

Big Pharma want to make it as expensive as possible, Marijuana works to get rid of pain if you don't mind getting high. I mind and just want the natural painkiller, but for now there's only Big Parma painkillers. Those who are holding on to it aren't helping anyone.

23/07/2014

Malcolm White

Please can you tell me where I can purchase this spray.

20/08/2014

Scarlet Palmer

Hi Malcolm,

Sativex is currently only available with a prescription from a doctor in the countries where it has been approved for medicinal use. If you are in one of those countries, asking your doctor about it is the only way of obtaining it at this time.

My apologies for the delay in replying to your comment, all comments are moderated before being posted so there is sometimes a lag.

Thanks for commenting!

29/08/2014

Katija Kara

I am a cancer patient and had undergone a chemotherapy with abraxine.
The side effect is very severe with this neuropathic pain.Ihad tried different strong pain killers but to no avail.
Ihad also taken different drugs for this neuropathic pain but still is so aggressive.
I think of trying to take this SATIVEX
How would you suggest me
Please I am waiting to hear from you
Thank you
kara

01/10/2014

Scarlet Palmer

Hello Kara,

Thank you for reading and commenting. My sympathies with your condition. There have been quite a few studies showing positive results for using Sativex to alleviate neuropathic pain, mostly focussing on people with MS. I also discovered this study on treating chemotherapy-related neuropathic pain with an oral cannabinoid extract, nabiximols, which is another name for Sativex - the study concluded that further research should definitely be done since results were promising.

However, as with all self-medication, we must recommend that you check with your current medical practitioner(s) before using cannabis as a medicine - or indeed at all, if you have a pre-existing condition. Sativex is currently only available on prescription, so consulting your doctor about it would be your best next step.

Wishing you all the best, much strength and support to you,

Scarlet

01/10/2014

pascalito

hello where can I buy sativex (I'm french)

02/10/2014

mandy

my mum has secondary bone cancer and I want the try sativex for her pain. Somebody help me get hold of this stuff from somewhere I can trust ....

22/10/2014

Seshata

Hi Mandy.

If you're in the UK, Sativex is available on prescription - but you are subject to a 'postcode lottery', and according to your location you may have more or less difficulty obtaining a prescription from a GP. Furthermore, Sativex is unfortunately only currently approved for MS-related muscle spasticity, although it is also currently undergoing Phase III clinical trials for cancer pain. Therefore, you're going to have real trouble acquiring Sativex at this stage for your particular requirements. I believe that Sativex was deemed uneconomical by the authorities in England this year, but that Welsh authorities have OK'd it. If you live in or close to Wales this may be of some help. But I expect that you would have to wait for the clinical trials on cancer pain to be completed and declared successful.

Apologies that I do not have more encouraging news, and I wish you every success in your efforts to assist your mother.

Regards,

Seshata

27/10/2014

Robert

My osteopath has recommended Sativex to help manage acute back pain caused by spinal stenosis. is this an appropriate use? Where may I buy it in Spain, France and Switzerland -the countries that I travl to and from most?
Thank you.

26/10/2014

Seshata

Hi Robert. I believe that Sativex is currently available on prescription in Spain, and I believe that France and Switzerland are among the 8 European countries soon to launch. As it is prescription-only, you will need to visit a doctor or GP to discuss how you can access the medicine. Cannabis and cannabis tinctures are widely used for management of chronic pain, so I imagine that Sativex would afford some relief, although it is only approved for MS-related muscle spasticity so I question whether a GP would prescribe it for your condition. Given that you travel to Spain frequently, I would advise becoming a member of a social club - the financial outlay to obtain your medicine will probably be less, and with trial and error, an ideal dosage and delivery method can be designed that is unique to you.

27/10/2014

Suzanne

When will sativex be available in pharmacies in France on prescription.
I have waited two years. Is there a definite date yet when my neurologue can prescribe it to me please.

05/01/2015

Seshata

I'm afraid I cannot help there, but if you contact GW Pharmaceuticals or Almirall directly they may be able to give you an answer.

05/01/2015

michael hartigan

i live in Ireland can I buy sativex online

06/01/2015

David Cannafacts

Hello Michael,
As far as I am aware, Sativex is only available through prescription.

Take care!

06/01/2015

annelu

H I suffer extreme pain caused by hemiplegia spasticity(as per MS).. from a stroke... It has just occurred to me that medicinal cannabis may be able to help with the pain management. I was cheered at the hope there is a way I can have a life without pain, straightaway I read that it is not possible to get this help ion the UK !! should I move ?I live in east London and am seriously disabled even a visit to the go is what can I do next to change this unhelpful situation with thanks annelu

21/02/2015

suzanne

when will sativex be available on prescription in France. I have been waiting two years but my neurologue says it has still not been authorised.

02/03/2015

David Cannafacts

Hello Suzanne,
The changes in French law clearly indicate medicinal cannabis can now be prescribed but few doctors seem to be willing to take the first step.
However, I have heard of a couple cases in which Sativex or even Bedrocan (herbal cannabis) were prescribed by French doctors. The problem was that the patients needed to travel to the Netherlands or Germany to obtain their medication as French pharmacies do not yet distribute it.

06/03/2015

Suzanne

When will sativex be available in france

19/03/2015

Waqas khan

any update is it available in Pakistan ???

19/07/2015

Vincent Buckley

I live in Ireland and I am suffering chronic pain for the last 2.5 years following a right neck dissection for the removal of (scc) nodes from my neck. My accessory nerve and trapezius muscle were severed leaving me in constant agony.

I have tried every form of pain relief and have travelled long distances but nothing has helped. Unfortunately it is not available here yet. I would appreciate if you could let me know how pain suffers in my situation can access Sativex.

Yours sincerely,
Vincent

21/07/2015

Stefanie

Hi Vincent,
Thank you for reaching out to us. Have you asked your physician about Sativex? Also, in Ireland there is an non-governmental organization called M.E.D.I.C Ireland For Cannabis Law Reform. Perhaps they can help you with information? Or try the United Patients Alliance in the UK.

Best of luck -
Stefanie

21/07/2015

Zari

I have been looking to find how to get medicinal cannabis for my mum that has cancer. Your information was very useful.

05/08/2015

elvira

good morning
meaby someone do you know where is possible to buy sativex?
i'm from italy and i dont find a doctor who write me a prescrition for to buy in farmacy
i'm 82 years old and i have some healt problems
i found in internet but i could buy per almost 1000euro
thank you
best regards
elvira

03/09/2015

Thomas Lindblad

It is strange that even if approved for MS in Sweden, you may hear from your neurologist that "we have deceided not to prescribe Sativex". Can it be so hard to understand that you may want to try it and see if it helps. What is the big problem? Is it that it is a cannabis derivative and that is BAD. I have never used drugs, but I would like to try one dose of Sativex, but I got a "NO" from thre MD:s.
// Thomas

24/02/2016

Irfan

Hi Everyone
After two major car accidents in around d 2001, I have been in constant pain. I'm told that it is a form of fibromyalgia called chronic acute myofascial pain syndrome.
I've chipped or broken all of my teeth because of the impact of clenching my teeth when I have a pain attack. I have sustained a concussion several times because of falls. I can't sleep - I now sleep between 5 and 15 hours per week. I'm in constant pain.
For about 12 years I took Oxycodone (& a cocktail of other drugs) in November of 2015, my Oxycodone was up to 1,600 mg per day! I made the decision then to completely withdraw from the opiates because I felt crcrtain that they were doing more harm than good. I started to tritate down on Christmas Eve and took my last OXY on February 12, 2016. Paramedics were called countless times be ause of the impact of withdrawal. My GP was here almost every day, but the tears flowed and I went through an extraordinarily tough time.
Now, I'm left with the overwhelming pain and everything that goes with it - depression, suicidal thoughts, insomnia, dysfunctional relationships and I'm bed bound.
I've brought up Sativex with my GP countless times, but he shuts me down every time. I clearly haven't responded to the plethora of drugs I've been taking and now want the opportunity to try Sativex. I know that he can prescribe it 'off licence' and the pharmacist can dispense it 'off licence', but my GP is entirely unwilling to have that conversation.
I live in Wimbledon, in London. What can I do? Who can I appeal to? Who can I write to? I feel so completely defeated.
The worst thing is that I see a team (a multi disciplinary team) with expertise in pain management at my local hospital. They are also as unaware and opposed to the idea of medical marijuana or Sativex as my GP.
I feel so desperate that words cannot describe. PLEASE, PLEASE, PLEASE give me some direction.
Kind regards

11/05/2016

Scarlet Palmer

Hi Irfan,

I am really sorry to hear about your struggle to properly manage your pain, and I have so much respect for you for coming off opiates. Although Sensi Seeds cannot give medical advice as we are not healthcare professionals, I would like to suggest the following (forgive me if you have tried these already, I'm going off the information in your comment):

This post has a lot of information directly aimed at healthcare providers who need information about cannabis-based medicines and medicinal cannabis. There is a section on Sativex with a link to the GW Pharmaceuticals site, the manufacturers of Sativex, which provides detailed information for prescribers. You could request your doctor and the hospital pain management team to read it, and also ask for a second opinion from another doctor. Although UK law does not give the right to a second opinion, according to the NHS website requests are "rarely refused". This research paper may also be useful to show to your doctor and healthcare team as it specifically mentions fibromyalgia (see Conclusion).

I also recommend you get in touch with the United Patients Alliance, as they have a growing network of people and resources and may be able to offer you some support. They are on Facebook and hold various events and meetings.

I hope this helps, and wish you all strength and support.

With best wishes,

Scarlet

12/05/2016

Margarita

Hi,
I am interested to know when would Sativex be available in Bulgaria?
Thank you!

31/05/2016

Scarlet Palmer

Hi Margarita, thank you for your comment :)

As Sensi Seeds is not connected with GW Pharmaceuticals, the company that makes Sativex, I cannot easily answer this question and I also cannot find any information online for you - the Sativex availability page on the GW website is quite out of date! The only thing I can think of to recommend is that you contact GW Pharmaceuticals directly and see if they can tell you, or perhaps ask your doctor if they have any information. Sorry I cannot help you further! If you do find out, I would appreciate you leaving another comment to share this information with other readers who may have the same question. Thank you again,

With best wishes,

Scarlet

01/06/2016

Gracie

I am inWashington, DC. I have MS and would like relieve pain in my body. I also have urinary/fecal incontinence. I've never smoked marijuana. Would you suggest smoking marijuana or cannibus?

20/07/2016

Scarlet Palmer

Hi Gracie, thanks for your comment. We are sorry to hear about your condition.

As Sensi Seeds is not a medicinal practitioner, we are unable to give advice about medical issues and we can only recommend that you consult your doctor or other licensed healthcare professional. When you do, it may be useful to share this article with them, which was written specifically to aid healthcare professionals who may not be familiar with the various medicinal uses of cannabis.

I hope this helps,

With best wishes,

Scarlet

20/07/2016

Rob

Hello, I have Post Herpetic Neuralgia following on from Shingles.
I am taking Gabapentin up to 180mg a day for the pain.
Is Sativex suitable for me on prescription>

13/09/2016

Scarlet Palmer

Hello Rob,

Thank you for your comment. We are sorry to hear about your condition. Unfortunately, as Sensi Seeds is not a medical practitioner, we are unable to give any advice on these kind of questions beyond recommending that you ask your GP or other registered medical professional. You may find this post on information about cannabis for medical and healthcare professionals helpful if you decide to ask your doctor about it.

Wishing you the best of luck,

Scarlet

14/09/2016

Joanne Tracey

Hi is this now available in UK for anything other than MS pls?

23/10/2016

Scarlet Palmer

Hi Joanne,

Thank you for your comment. As far as I know, Sativex is currently only approved for MS treatment in the UK.

With best wishes,

Scarlet

24/10/2016

Melanie

I was diagnosed with RRMS IN 2009 and had been told by an radiologist of possible MS about 2007. The diagnosis didn't happen until I was in the hospital for 5 days with pnumonia which got me to quit cigarettes. I was started on Rebif then switched to Copaxone because of blood tests then when by neuro Dr. Didn't like the MRI results he asked if I wanted to change meds and that there were now pills available of which I chose Tecfidera without reading all the info. I had a definite relapse in Jan. 2015 losing the sight in my left eye and was put on IV steroids for the next 3 mornings which caused my husband to take time off to drive. My Depression had gotten so bad I fidn't want to exist anymore so I took a hit off a houka to see if it would help and it did. Then my daughter told me NOT to do that again so I started to smoke cigarettes again to releive the Anxiety. A friend of my daughter whose father is terminally ill told me about CBD "jungle juice" and that it is recommended to her father by his Dr. So I tried it and it really helped me. Now they have made CBD schedule 1 and it is hard to find in Florida since it passed for medical marijuana in the last election. Any idea what to do? My neuro to me Biotin but that I couldn't tell anyone. I wasn't told why but is Biotin helping me or killing me? Is it a prob with the Tecfidera or my Metformin which my GP has me on Losartan for my Kidneys? HELP.

29/12/2016

Scarlet Palmer

Dear Melanie,

Thank you for your comment. We are sorry to hear about your situation. Unfortunately, as Sensi Seeds is not a medical practice, we are not able to provide any advice relating to medical situations other than to consult your doctor or other licensed medical professional. This article, written specifically for healthcare providers who may not be aware of the many properties of cannabis, may be useful to you in talking with your doctor. You could also try to contact local medicinal cannabis support groups, if you have not already done so. In the UK, there is the United Patients Alliance (you can find them on Facebook) and in the US and EU there are many branches of NORML (google NORML followed by your area name). We hope this is helpful.

With best wishes,

Scarlet

30/12/2016

Ann Jakobsen

Hi. I have Multiple Sclerosis, double sided Trigeminal Neuralgia and cluster headaches. I live I'm Norway and am desperate for relief.I have multiple spasticity and both neurological and doctor verification for all threes. Sativex is allowed for MS patients her in Norway, but the waiting list is extreme, but my pain worse. We are allowed to import from the Netherlands as long as we check in with customs. Please can somebody put me in contact with the appropriate doctor/doctors who can prescribe this as I am literally living in nerve pain he'll. I also have a two year old who has seen me take so many shots, pills, oksygen etc that it breaks my heart to seek her get to used to it she actually tries to help me now with the oksygen tank. Can you please refer a doctor whom I can present the proper documentation and get this more natural medicine prescribed? I am desperate and any help will be greatly appreciated. Sincerely Ann

31/07/2017

Jon

Prøv Smertemedisinsk institutt på Majorstua. Du må ha henvisning fra fastlege. Min kone har fått der, men det koster 4700,- for 3 sprayer. Får det ikke dekket av helfo med mindre du ha MS desverre.

09/10/2017

Jamie McFarland

I come from Australia how can l purchase

02/11/2017

Scarlet Palmer

Hi Jamie,

My best advice would be to consult your medical practitioner as to the availability of Sativex in your area. You might also find this article interesting, although it is from last year and medicinal cannabis is legal in some parts of Australia now, but there are some links that you might find interesting. This article has been written specifically for healthcare providers and you might want to share it with your doctor if they are not up to date on the medicinal uses of cannabis. There are also branches of NORML throughout Australia, who might be able to help; just google NORML followed by your area name.

With best wishes,

Scarlet

02/11/2017

andrew borg nicolas

can someone help me please i need sativex badly i live in malta i have ms it will be the best gift of my life it is legal to have medical mariuyana thank you so much

17/11/2017

Scarlet Palmer

Dear Andrew

Thank you for your comment. We are sorry to hear about your situation. Unfortunately, as Sensi Seeds is not a medical practice, we are not able to provide any advice relating to medical situations other than to consult your doctor or other licensed medical professional. This article, written specifically for healthcare providers who may not be aware of the many properties of cannabis, may be useful to you in talking with your doctor. You could also try to contact local medicinal cannabis support groups, if you have not already done so. In the UK, there is the United Patients Alliance (you can find them on Facebook) and in the US and EU there are many branches of NORML (google NORML followed by your area name). We hope this is helpful.

With best wishes,

Scarlet

17/11/2017

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