Sativex® approved in Germany for treatment of MS spasticity

A cannabis derived drug which has been approved in some countries to treat muscle spasticity.

Sativex® approved in Germany for treatment of MS spasticity

Postby MSUK » Thu May 26, 2011 1:16 am

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Almirall, S.A. and GW Pharmaceuticals plc today announce that the health authorities in Germany have granted regulatory approval for Sativex®(Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to Multiple Sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medication(i). Sativex® is expected to be launched in Germany in July 2011.

Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). The medicine is already available for MS patients in the UK and Spain.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1814
MS-UK - http://www.ms-uk.org/
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Re: Sativex® approved in Germany for treatment of MS spastic

Postby HarryZ » Thu May 26, 2011 7:33 am

Gee it's taking a very long time for the various governments to approve this medication. You have to wonder if its association with MJ is slowing this process down unreasonably.

Developed in the UK in the late 90's, the first country to approve it was Canada (I think in 2004 ) It does work for many MS patients albeit a bit pricey to use for a long period of time.

Harry
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Postby THEGREEKFROMTHED » Thu May 26, 2011 10:47 am

the stiffness in my back is so painful....every stinking day....will it ever make it to the glorious usa?
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Postby Lyon » Thu May 26, 2011 10:53 am

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Last edited by Lyon on Wed Jun 22, 2011 5:50 pm, edited 1 time in total.
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Postby HarryZ » Thu May 26, 2011 11:16 am

THEGREEKFROMTHED wrote:the stiffness in my back is so painful....every stinking day....will it ever make it to the glorious usa?


As Lyon wrote, some states in the US have laws making MJ available to them.

Unfortunately, many legislators in the US lose all reason when it comes to discussing MJ. Often they ignore the science and listen to the politics.

I live in Canada and have talked to a neuro who has researched MJ for pain for a number of years. He told me that the docs here have to keep their work low key for the very same reason....if the politicians get involved, all hell breaks loose!

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Postby THEGREEKFROMTHED » Thu May 26, 2011 12:15 pm

I am in michigan and have obtained the "card" but dispenseries are still unavailable in most cities (which is a joke) and it just makes me so damn loopy i cannot function...Ive tried it in cookies and teas, but same thing....this stifness is my nemesis and is literally controlling me..I wonder if the sativex would help? I could go across the border, but not sure about getting back!
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Postby HarryZ » Thu May 26, 2011 1:51 pm

THEGREEKFROMTHED wrote:I am in michigan and have obtained the "card" but dispenseries are still unavailable in most cities (which is a joke) and it just makes me so damn loopy i cannot function...Ive tried it in cookies and teas, but same thing....this stifness is my nemesis and is literally controlling me..I wonder if the sativex would help? I could go across the border, but not sure about getting back!


To get Sativex in Canada, (Ontario in your case) you would require a RX from a doctor licensed in Ontario. I know that there are some docs who practice in Michigan but also keep their Ontario licenses so they can write a script for you.

Good luck.

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Postby willowford » Thu May 26, 2011 2:37 pm

HarryZ wrote:
THEGREEKFROMTHED wrote:the stiffness in my back is so painful....every stinking day....will it ever make it to the glorious usa?


As Lyon wrote, some states in the US have laws making MJ available to them.

Unfortunately, many legislators in the US lose all reason when it comes to discussing MJ. Often they ignore the science and listen to the politics.

I live in Canada and have talked to a neuro who has researched MJ for pain for a number of years. He told me that the docs here have to keep their work low key for the very same reason....if the politicians get involved, all hell breaks loose!

Harry


I've heard from neurologists in Canada that there's also an issue of "liability" with being known to prescribe MJ or cannabis-based medicines (like Sativex). There's some practice insurance problems but I'm not clear on the details. The other aspect of liability is things like prescribing it to too many ppl makes it more likely that someone will not follow their "advice" on how to take it, and something bad happens (one example: told not to drive after taking med even if they feel like they can, but then someone drives and gets into an accident or gets pulled over). These things can be a problem with a lot of other meds too, which some docs are also hesitant to prescribe regularly.
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Postby HarryZ » Thu May 26, 2011 7:26 pm

I've heard from neurologists in Canada that there's also an issue of "liability" with being known to prescribe MJ or cannabis-based medicines (like Sativex). There's some practice insurance problems but I'm not clear on the details. The other aspect of liability is things like prescribing it to too many ppl makes it more likely that someone will not follow their "advice" on how to take it, and something bad happens (one example: told not to drive after taking med even if they feel like they can, but then someone drives and gets into an accident or gets pulled over). These things can be a problem with a lot of other meds too, which some docs are also hesitant to prescribe regularly.


Have to admit that I haven't heard of this problem with Sativex. The kind of danger that you describe can occur with many rx drugs and certainly isn't limited to MJ based ones. Wonder if it's the typical biased attitude taking over when it comes to this situation.

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Postby willowford » Thu May 26, 2011 7:40 pm

HarryZ wrote:
I've heard from neurologists in Canada that there's also an issue of "liability" with being known to prescribe MJ or cannabis-based medicines (like Sativex). There's some practice insurance problems but I'm not clear on the details. The other aspect of liability is things like prescribing it to too many ppl makes it more likely that someone will not follow their "advice" on how to take it, and something bad happens (one example: told not to drive after taking med even if they feel like they can, but then someone drives and gets into an accident or gets pulled over). These things can be a problem with a lot of other meds too, which some docs are also hesitant to prescribe regularly.


Have to admit that I haven't heard of this problem with Sativex. The kind of danger that you describe can occur with many rx drugs and certainly isn't limited to MJ based ones. Wonder if it's the typical biased attitude taking over when it comes to this situation.

Harry


Oh absolutely. As I mentioned in my post, these things can be a problem with a lot of other meds too... sedatives for instance... which many docs are ALSO hesitant to prescribe routinely (unless absolutely required). (most walk-in clinics for instance have signs that say that the doc won't prescribe sedatives or stimulants).

The problem isn't always biased attitudes. We don't know the personal opinions of these docs; for all we know, they have the same likelihood of having used cannabis recreationally in the past as anyone else in the population! So there's really no evidence that all docs are purely anti-MJ on principle (some are just as some patients are too).

One issue that I personally think MIGHT be involved (I don't know that there is evidence of this either but), is that as humans we tend to fear what we don't know a lot about. This is especially true in medicine because as a doctor, you would be influencing OTHER people's lives, not just your own - so there's a huge sense of liability that you might not have when it comes to deciding for yourself.

Because cannabis and cannabis-based medicines is newly being researched and understood, there's some hesitancy at first about the findings. Even though studies show some beneficial effects on certain symptoms, some might be worried about other effects that haven't yet been studied thoroughly (long-term effects, cardiovascular risks, cognitive functions, other potential things that haven't yet been studied thoroughly). And so some docs may not feel comfortable taking a risk on someone else's (the patient's) behalf.

As more information comes out about positive and adverse effects, it might become less of a "worrisome" thing for docs to consider this treatment. Even if there are adverse effects (like all drugs), at least knowing what they are and being able to give all info to patients to let them decide (currently this isn't possible because of insufficient evidence, especially for smoked MJ), would help docs feel safer prescribing it.

p.s. I'm only referring to medical professionals, who follow the literature and medical guidelines. The political stigma/bias/etc are probably different and not my place to comment on.
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Postby THEGREEKFROMTHED » Fri May 27, 2011 6:59 am

this may be an impossibility, but should someone know of a practicing physician in Canada that would write me a script please pm me.
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Postby willowford » Fri May 27, 2011 7:15 am

THEGREEKFROMTHED wrote:this may be an impossibility, but should someone know of a practicing physician in Canada that would write me a script please pm me.


Sorry, I wish I had a name. I work with MS patients in Canada - and several have the prescription. Try looking into "pro-MJ" sites, sometimes they have lists, especially since it is legal in Canada for medicinal purposes. Are you a Canadian resident though? If not, it's much less likely you'll find someone in Canada to prescribe it to a US resident (cause laws in US are so variable).
If you're looking for Sativex, your luck would be much better; because it doesn't have the adverse effects of inhalation, so docs are more willing to prescribe it.
The other med in this category that is still being used is Marinol; it's older but there's evidence that it's beneficial sometimes. The difference is that Sativex is a oromucosal spray that you can titrate yourself, whereas Marinol is a tablet (or capsule?) like other drugs.
I've seen patients that have responded with improved symptoms with these meds (and other similar ones), and others who have not, and still others who had side-effects that they couldn't handle (everyone has some side effect, if severity is low compared to benefits, then they keep using it). Like a lot of meds, there's variation.
I assume your regular docs were not receptive to the idea? Even the non-smoking types? How I would approach it if you haven't is tell them your symptoms and that they are affecting your life greatly. And you have heard that there is evidence that Sativex/Marinol have helped many patients and that you'd like to give it a trial shot for a bit.

Hope you have some luck.
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Postby HarryZ » Fri May 27, 2011 7:40 am

THEGREEKFROMTHED wrote:this may be an impossibility, but should someone know of a practicing physician in Canada that would write me a script please pm me.


What border city in Canada are you closest to?
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Postby THEGREEKFROMTHED » Fri May 27, 2011 11:06 am

30 MINUTES FROM WINDSOR...
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Postby THEGREEKFROMTHED » Fri May 27, 2011 11:14 am

my neuro is all about major drugs and thats about it..Not sure of a neuro in the area that would prescribe me the sativex....
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