Friday, 23 October 2015

Sativex in real life..Most people feel benefit

Ferrè L, Nuara A, Pavan G, Radaelli M, Moiola L, Rodegher M, Colombo B, Keller Sarmiento IJ, Martinelli V, Leocani L, Martinelli Boneschi F, Comi G, Esposito F.Efficacy and safety of nabiximols on multiple sclerosis spasticity in a real-life Italian monocentric study. Neurol Sci. 2015. [Epub ahead of print]

Multiple sclerosis (MS) patients frequently suffer from limb spasticity and pain despite antispastic treatments. To investigate nabiximols efficacy and safety in a real-world monocentric Italian cohort, the following data were collected at baseline, week 4, 14 and 48: Ambulation Index (AI), 10-min walking test (10MWT), combined Modified Ashworth scale (cMAS), scores at numerical rating scale for spasticity (sNRS) and pain (pNRS). Responder status was defined as a ≥20 % reduction in sNRS after 4 weeks of treatment. 144 MS patients (123 progressive and 21 relapsing-remitting) complaining of moderate-to-severe spasticity (mean sNRS: 7.5) were included: 138 (95.8 %) completed the first month of therapy and were classified as follows-23.2 % were non-responders, 5.1 % were responders but discontinued treatment due to side effects, 71.7 % were responders with a mean 32 % reduction in sNRS (p < 0.001). In responders sNRS further decreased between 4 and 14 weeks (p = 0.03). Similarly, pNRS improvement was seen during the first month and between 4 and 14 weeks (p < 0.001 and p = 0.004, respectively). Moreover, at 4 weeks responders showed a significant (p < 0.05) improvement in cMAS, AI and 10MWT, which was maintained at 14 weeks. At 1-year follow-up, a benefit was still evident on spasticity and painful symptoms with a low drop-out rate. Confusion/ideomotor slowing, fatigue and dizziness were the most frequent side effects; no major adverse events were reported. Shorter disease duration at treatment start was associated with better response. This real-world study confirms nabiximols efficacy and safety in the treatment of MS-related spasticity and pain, which is maintained up to 48 weeks.

You can all read and can see that in real life sativex is giving some benefit in the majority of people who use it. The interesting thing is that a positive effect was seen in the Ashworth Scale  (physician based scale) where this outcome failed to be affected in early trials. Why is is not universally available in the UK?

The answer is postcode and cost and NICE, as they consider it not cost effective. It is always going to difficult for expensive symptom control drugs to make it through NICE. However there haven't been new symptom modifying drugs for decades and this is unlikely to change if companies think that they can't make money out of them.

CoI. We are developing competing molecules

9 comments:

  1. Sativex is expensive but the plant costs pennies on the dollar to grow in some places.

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    1. Sativex won't get you nicked by Plod though.

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  2. It is ironic that Sativex is produced in the UK yet the patients in the UK cannot access the drug. Other EU countries report efficacy. If the regulatory agency deems it is not cost effective they should provide an equally effective alternative. Did Sativex fail in clinical trials? Every time I read abstracts on the benefits of marijuana extracts and yet the failure to provide the drug I scratch my head in disbelief. Maybe GW Pharma should refrain in using the term marijuana. The stigma seems to be its main impediment.

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    1. Yes there is still some stigma surrounding cannabis/marijuana as a medication. Sativex has shown efficacy in clinical trials (when eventually the trials were done correctly) but the decision to charge too much for it has meant that it is not recommended by NICE as cost effective in the UK so many pwMS in the UK who could benefit from it are losing out.
      GW now seem to be putting a lot of effort into CBD for epilepsy treatment.

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    2. I get the impression that GW is exhausted dealing with the perception that cannabis can only lead to "reefer madness". I don't envy their marketing dept.

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    3. They dont really have one as they have Bayer, Almiral, Novartis Otsuka, ipsen doing their distribution.

      However the authorities in the USA run a mile from cannabis whilst you have the stoners on the other extreme and the legalise medical marijuana

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  3. I asked my GP about Sativex recently, what the state of play is regarding prescription. He kind of laughed when I said; "The cannabis-derived one - Sativex." I thought a drug derived from a "herbal" might have less side effects. But no - Sativex carries quite some side effects. One is also unlikely to be prescribed expensive Sativex without proving to be unresponsive to Baclofen, so my GP said. In the end, considering the side effects of both would probably negate their benefits for me, I've opted to live with my symptoms. I hope the "competing molecules" you're developing have less unwanted, unhelpful effects.

    Maybe I would have tried the real thing, but I know from a case I heard of some time ago that UK law shows no leniency towards people with MS who grow it for medicinal purposes. A real shame. Maybe. (It wouldn't be great to end up psychotic with PPMS to boot.)

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