Sativex Study Reports Positive Results in People With MS

Ed Tobias avatar

by Ed Tobias |

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Could a cannabis spray be just what the doctor ordered to treat our MS symptoms? I’m talking about Sativex (nabiximols), which has been developed as a treatment for moderate and severe MS spasticity.

Sativex combines THC, the chef intoxicant in marijuana, with CBD, marijuana’s nonpsychoactive component. It’s sprayed under the tongue or inside the cheek several times a day. The treatment has been approved in several countries, including the U.K. and Canada, but in the U.S., it’s still considered to be investigational. A Phase 3 trial is underway.

Brussels study reports positive results

A small study in Belgium, published in BMC Neurology in late June, contains encouraging news about Sativex for people with MS. A group of 238 people with MS used the treatment several times a day for 12 weeks. During the study, two tests were given: the Numerical Rating Scale (NRS), which measures pain (with a 10 being the worst), and the EuroQoL Visual Analogue Scale (EQ VAS), a self-assessed quality of life rating (with 100 being the best).

NRS scores improved from 8.1 at baseline to 5.2 at week four, 4.6 at week eight, and 4.1 at week 12. EQ VAS scores increased from 39 at baseline to 52 at week four, 57 at week eight, and 59 at week 12. Scores on both tests remained at the 12-week level in some smaller groups whose participants continued to be tested for as long as 12 months.

The authors of this study conclude that, “More than 60% of the patients with MS who started add-on treatment with cannabinoid oromucosal spray reported a clinically relevant symptomatic effect and continued treatment after 12 weeks.”

A friend tells me about his Sativex experience

About the same time the BMC Neurology report was being published, I heard from Daniel Verbeke, a reader of my column who lives in Belgium. Daniel has been using Sativex since last January and reports mixed results.

In an email, he wrote that by starting at one spray a day and building up to eight, he saw “no spectacular improvements.” But the spasticity in his right leg decreased, and he said he was “in a much better mood” to walk with a walking stick, when previously he would often use a wheelchair or scooter.

Daniel told me he felt none of the “high” associated with marijuana and had no side effects, such as a headache or dizziness.

“It’s not that much, but enough for me to continue the therapy,” he wrote.

Daniel told me that in Belgium, the price of three Sativex bottles is 24 euros ($28.50) with a prescription. Without one, the price jumps to 922 euros ($1,093.22). Wow!

I wonder how many people will think the results are worth the cost, and whether, if approved in the U.S., insurance will cover it.

You’re invited to visit my personal blog at www.themswire.com.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Comments

Elizabeth Williams avatar

Elizabeth Williams

It sounds like it's at least worth a try, but I wonder about one thing. I tried small doses of cannabis at night a few months ago (I live in Massachusetts, so it was legal, even without a prescription). It helped with muscle cramps, I slept like a rock, and I didn't feel at all high. The problem was that the next day, I had a hard time concentrating on work. Does Sativex cause even mild mental impairment?

Reply
Ed Tobias avatar

Ed Tobias

I don't know, Elizabeth. However, my friend in Belgium told me he had no high and no side-effects. I guess we'd need to see what the clinical trials report and, hopefully, we'll have that info by the end of the year.

Ed

Reply
Dorothy Levinson avatar

Dorothy Levinson

Why are we always the LAST country to get new ttreatments for our citizens. And the treatments cost much more here, too. We used to be first in everything but not now. How sad.

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Jane avatar

Jane

This is great news! Question: Is Sativex synthetic? With the side effects of other medications for MS, and if Sativex is naturally produced, it would definitely be worth a try.

Insurance coverage in the US is another thing altogether - most do not cover alternative therapies known to produce positive effects, such as massage therapy and acupuncture. It saddens me to say that I don't expect any exception for this valuable addition to pain management - until and unless the powers that be get involved. Hopefully they will get involved because this is most probably a game changer for many issues people with MS have to deal with.

Reply
Ed Tobias avatar

Ed Tobias

Hi Jane,

I don't know the pharmacology of Sativex. Howwever, GW Pharmaceuticals says it's intended for use with other anti-spasticity medications. The company intends to apply for FDA approval of Sativex, so I don't think it would be considered an alternative therapy. Fingers crossed on insurance.

Ed

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Brian O’Neill avatar

Brian O’Neill

Sounds promising. When will trial #3 be over? I hope insurance covers it. Thanks.

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Ed Tobias avatar

Ed Tobias

Hi Brian,

GW Pharmaceuticals has two trials underway in the U.S. and is planning three more. All are studying the effect of Sativex on MS spasticity. A news release from the company says it hopes to have results from one of the studies before the end of this year.

I also hope insurance will cover it, if it gets approved.

Ed

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Maree Foxcroft avatar

Maree Foxcroft

Was wandering if this wld b suitable for my PPMS

Reply
Ed Tobias avatar

Ed Tobias

That's hard to say, Maree. It probably would be but think we'll need to wait until the clinical trials end to really know.

Ed

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Kathy B avatar

Kathy B

I began taking THC gummies last year (2020). They were wonderful. I took one every night at bedtime. I was able to sleep so well and noticed less rigidity in my legs. Unfortunately, I had a blood test last November for my MS and my leukocyte count was abnormally low. THC can reduce your leukocytes. Thus, I had to stop. It was a letdown, for sure.

Reply
Ed Tobias avatar

Ed Tobias

Hi Kathy,

Thanks for sharing. I didn't know that about THC so I'll have to do some reading and educate myself. Sorry you had to stop.

Ed

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SUSAN Ratcliffe avatar

SUSAN Ratcliffe

Hopes are continually frustrated by tight-fisted CCG's. Decisions as to which MS patients can benefit from a Sativex prescription still appears to be a postcode lottery.

Reply
David lawrence Kirchner avatar

David lawrence Kirchner

You gave the cost of a bottle, no clue as to how long a battle lasts, 1hour? 1 day? 1 week? what?

Reply
Ed Tobias avatar

Ed Tobias

Davie,

You're right. I dropped the ball on that. I'll find out and get back to you.

Ed

Reply
Ed Tobias avatar

Ed Tobias

David,

First, apologies for the typo in spelling your name when I first responded. I've checked with Daniel and he says, at six sprays a day a bottle lasts five to six weeks.

Ed

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Anthony Hoysted avatar

Anthony Hoysted

Sativex is also approved in Australia for MS spasticity. To the best of my knowledge, it is an extract derived from naturally-grown cannabis plants. Its composition and the proportion of CBD and THC are carefully controlled.
However, in Australia, only a specialist neurologist can prescribe Sativex. It must be given a four-week trial, and other muscle relaxants must have been tried and found ineffective. More importantly, the cost is not subsidised by the Australian government (most medications are), and comes to around US$560 for 6-8 weeks' supply. I think this would mean that few people in Australia are trying it at present (if the person has private health insurance, it will cover some but not all of the cost of a year's supply). If at any time Sativex becomes subsidised under the Australian Pharmaceutical Benefits Scheme, the cost will come down to around US$30 per month or US$5 per month for low income earners, at which point I imagine many people with MS would try it.

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Ed Tobias avatar

Ed Tobias

Hi Anthony,

Thanks for sharing that great information. It's a shame that the national health service isn't supporting Sativex. I fear that the same will be true here in the U.S., even if our Food and Drug Administration okays its use for MS. I suspect you're correct when you assume people are probably not even trying it due to the expense. I hope we can pressure our decision-makers to put Sativex onto the list of the meds for which they will pay.

Ed

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Allan Kyte avatar

Allan Kyte

I am writing on behalf of my wife ,who is sadly a quadriplegic M.S sufferer . Fiona ,was a pioneer with regard to the use of Sativex ,some fifteen-twenty years ago ,having been a trialist for this product . In those days it was in tablet form ,which sadly settled in her stomach , made her anorexic ,and losing three stone ,in three months and being taken off it ,with some urgency.
Once it became available in spray form however ,she went back on the trials and has remained so ever since, with no ill effects what so ever and for anyone thinking about requesting it "DO SO ,WITHOUT HESITATION " as ,in our opinion after many years of constant use ,it has proven to be "THE BEST PAIN RELIEF,KNOWN TO MANKIND "Easy and quick to take and quick to take effect (providing that you stick to the recommended dosage) and quite
quickly eases ,what in her case are agonising spasms ,(particularly in her neck" which makes her scream aloud

Yours sincerely
Allan Kyte

( On behalf of Mrs. Fiona Kyte)n

Reply
Ed Tobias avatar

Ed Tobias

Hello Allan,

Thanks very much for taking the time to share your wife's experience. It's wonderful that she's done so well with the Sativex spray. I know others who read what you wrote will be very grateful for that information.

My best wishes to Mrs.Kyte,

Ed

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DJ avatar

DJ

Hi Ed,

here's my report about it, being a male with PPMS diagnosed about a year ago.

My neurologist gave prescribed it to me for a "try" and after several days I can report absolutely no effect. I do have previous youth experience in cannabis so maybe this has effect only on those who never smoked it, I can't tell. In addition, the aftertaste is just horrendous! Who designed this to spray it 12x a day directly into your mouth?! Makes me want to vomit on 5th application. Very repulsive.

On another note, can you explore possibility to add "night mode" to your site? White background puts enormous strain on my eyes and inverted works great but i can't use high contrast scheme most of the time as I'm an IT professional where most of healthy do not really care about those like me with optical nerve sensitivity while doing design of their websites and where most IT tools are not optimized for it.

Thanks!

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