Thursday, 30 August 2012

Research: sativex can alleviate spasticity in mice


This study investigated the anti-spasticity potential of Sativex in mice. Chronic relapsing experimental allergic encephalomyelitis was induced in adult ABH mice resulting in hind limb spasticity development. Vehicle, Sativex, and baclofen (as a positive control) were administered and the "stiffness" of limbs assessed by the resistance force against hind limb flexion. Vehicle alone caused no significant change in spasticity. Baclofen induced approximately a 40% peak reduction in spasticity. Sativex dose dependently reduced spasticity up to approximately a 40% peak reduction in spasticity. Sativex has the potential to reduce spasticity in an experimental mouse model of multiple sclerosis (MS). Sativex was just as effective as baclofen, providing supportive evidence for Sativex use in the treatment of spasticity in MS. 

The compounds within Sativex can inhibit spasticity in mice. Well no big shakes there Sativex has been licenced for the treatment of spasticty in Msers for a few years. Yes I know few PCT are funding it because it is too expensive. 

Well members of Team G showed that this should happen many moons ago and this study confirms this. The important thing is that mice can not talk to us and so if we can measure benefit, it is not that they are conned because of mind-altering effects, which is a comment often aimed at MSers who take cannabis. 

However, the reason why this is important is that the regulators such as the FDA like to see that drugs work in pre-clinical models. This works because it acts on a biology that is involved in the control of spasticity.

CoI: Work was undertaken by Team G and supported by GW Pharmaceuticals the makers of Sativex.  Other Members of Team G have generated potentially competing chemicals

14 comments:

  1. I am a bit confused sometimes with the evidence base that seems to influence commercial/health decisions. On the one hand you seem to suggest in some of your posts that evidence has to come from double blinded, peer reviewed stage III trials. On the other you offer above a suggestion that a mouse trial could be the thing that influences a decision, as mice can't talk. Has Sativex not done a double blinded, placebo study? And if they have - isn't this sufficient evidence for NICE etc.

    Is also the problem that doctors face the issue of gauging need? I am sure some spasticity is so obvious as to be self evident that help is needed. But others must suffer with silent spasms - nothing that disables but that causes constant pain.

    It strikes me that Sativex is just too costly in an age of tighter budgets. And I doubt a mouse trial is going to change that.

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    1. The problem is that for spasticity in humans, the assessment has historically been made by clinicians using a visual scale called the Ashworth scale. This is notoriously insensitive in showing any improvements with drug treatments, indeed many of the currently prescribed medications for spasticity perform poorly using the Ashworth scale. This has lead to more patient reported imporovements being used, which has shown improvements but are not objective.
      In our mice we use a strain gauge to measure just how stiff the limb is before and after treatment so it gives an objective measure that you can do stats on rather than purely subjective measures, which is what MD was alluding to. It also shows that in some situations, results from animal research can directly correlate to the human situation (despite what anti-animal research lobbyists might tell you.

      I agree that Sativex is far too expensive, hopefully this will change.

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  2. You are making the error that the work is only just been done now. However it was done long ago before regulators made their mind up, it only just seeing the light of day. We had a number of projects that have not seen the light of day yet.

    The clinical trials of course are the important thing but if you can show the underlying biology it is the cherry on top that help you get a licence with FDA and or EMA. It has nothing to do with NICE!

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  3. But won't a NICE recommendation for access result - like with Fingolimod - a legal requirement for Trusts to prescribe?

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  4. Yes you are right for the UK, but the UK is only a small part of the MS market, the USA is the money earner. At the moment sativex is doing good business in Germany

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  5. Has anybody done a treatment outcome analysis of g8 countries and MS? i.e. to see if those in Germany have a better quality of life than those in the UK with MS?

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  6. Für unsere Deutschen Leser ... Haben Sie eine bessere Qualität des Lebens?

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  7. Sativex, Sauerkraut und Sonne - what else do you need :-)

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  8. Hey, MouseDoc - How come your fluent in German? A man of many talents obviously.

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  9. MouseDoc, I am impressed by your German. His Slovenian is equally good!

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  10. Ja mojih slovenskih in nemških jezikov sta zelo dobro. Hvala Google translate

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  11. you're such a tease MouseDoc ;-)

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