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Date of issue: August 2013 This factsheet will be reviewed within three years Contents 1. Introduction 2. What is Sativex? 3. How does Sativex work? 4. Who can be prescribed Sativex? 5. How effective is Sativex in treating MS spasticity? 6. How is Sativex taken? 7. What are the side effects? 8. Does Sativex interact with other medicines? 9. Who should not be prescribed Sativex? 10. Funding of Sativex 11. Travelling abroad with Sativex? 12. Sativex for other symptoms and conditions 13. Legal position of cannabis 14. References This factsheet is for anyone affected by MS who needs basic information
about Sativex and should be used to support discussion with a neurologist,
Sativex was the first cannabis-based medicine to be licensed in the UK. It is
licensed for use in MS-related spasticity (muscle stiffness) when people have
found that other medicines have not worked well or found their side effects
2. What is Sativex?
Sativex is a mouth (oromucosal) spray formulated from two chemical extracts
derived from the cannabis plant and contains delta-9 tetrahydrocannabinol
3. How does Sativex work?
The way that cannabis derivatives, like Sativex, work is not fully understood
but discovery of the cannabinoid receptors, a natural system of receptors in
the human body, has provided some insight. Receptors are protein molecules
in or on the surface of cells to which a substance (such as a drug) can bind,
causing a change in cell behaviour or activity. The active ingredients of
Sativex exert their effects upon the CB1 receptor in the brain and the CB2
4. Who can be prescribed Sativex?
The established anti-spasticity drugs, such as baclofen, tizanidine,
gabapentin, pregabalin and clonazepam, remain the first line treatments for
MS spasticity. If these treatments are not working well or have intolerable
side effects, Sativex may be considered. The addition of Sativex means that
it may be possible to decrease the dose of other anti-spasticity medication
and so decrease any troublesome side effects.
Clinical trials investigating the effects of Sativex on MS spasticity
demonstrated that those people who experienced improvement (48%) did so
within four weeks of receiving the medicine1-4. Consequently, Sativex is
prescribed for a trial period, usually four weeks, in the first instance. If there is
no clear improvement in spasticity-related symptoms, Sativex will be stopped.
Treatment with Sativex must be started and supervised by a specialist doctor
with experience of treating people with MS spasticity such as a neurologist,
consultant rehabilitation specialist or consultant pain specialist. In some
areas, GPs can write prescriptions for Sativex but only under instruction from
The specialist doctor will conduct a full assessment of the severity of the
spasticity and an evaluation of the response to standard spasticity treatments
before considering if the person might benefit from Sativex.
5. How effective is Sativex in treating MS spasticity?
A phase III clinical trial4 investigating the effects of Sativex in over 500 people
showed that 48% of participants had 20% or more improvement in their
spasticity. Amongst those who responded, about three quarters had an
improvement of greater than 30% in their spasticity score within four weeks
when compared with those taking a placebo. Combined analysis of three
clinical trials confirmed the effectiveness of Sativex5.
6. How is Sativex taken?
Sativex is sprayed into the mouth either on the inside of the cheek or under
the tongue. The severity of spasticity symptoms varies from one person to
another so the number of sprays needed depends on the individual. At the
start of treatment, the prescribing doctor will advise on frequency and timing
of mouth sprays and may suggest a gradual increase until the most effective
The maximum dose of Sativex is 12 sprays per day. A gap of at least 15
minutes should be left between sprays. The doses can be spread over the
day in a way that suits the individual. The effectiveness of treatment should be
assessed from time to time to see if it should be continued.
7. What are the side effects?
You must not drive or use machinery when you first start Sativex and until you
The most common side effects are fatigue or dizziness. These tend to occur
in the first four weeks of treatment and wear off over time. Side effects can
also be reduced by taking fewer sprays or waiting longer between sprays.
Some people report pain in their mouths at the sites where the spray is
administered. To minimise this, sites should be alternated as much as
possible. Sativex has occasionally caused a brief loss of consciousness.
People who experience any significant side effects should not drive, operate
machinery or take part in any activity that could prove hazardous.
As Sativex is derived from cannabis, there were initial concerns that it might
cause drug dependence, be psychoactive or cause withdrawal symptoms.
However, studies into long-term use of Sativex in people with MS showed that
sudden discontinuation of treatment did not result in any significant
withdrawal-like symptoms although some people reported temporary changes
in their sleeping patterns, mood or appetite following discontinuation. The
lack of withdrawal symptoms suggests that dependence on the treatment is
highly unlikely6,7. In addition, Sativex did not affect cognition (thinking or
memory) or induce any mental health problems at the doses used8.
8. Does Sativex interact with other medicines?
The prescribing doctor should be made aware of all other medications that the
person is taking including over the counter and herbal medicines. Particular
care should be taken if this includes any sleeping pills, sedatives or other
drugs with sedative effects as combining these medicines with Sativex may
Also, Sativex is often given in addition to other anti-spasticity medication. The
addition of Sativex needs careful monitoring as there may be an increased
risk of falls until the best dose has been established.
Sativex may interact with alcohol and can affect coordination, concentration
and the ability to respond quickly. Alcohol should be avoided especially at the
beginning of treatment or when changing dose.
9. Who should not be prescribed Sativex?
People should not be prescribed Sativex if they:
• Have an allergy to cannabinoids or the other ingredients of Sativex –
propylene glycol, ethanol and peppermint oil
• Have a known or suspected personal history, or family history, of
schizophrenia, psychosis or other significant psychiatric disorder. This
does not include depression which is part of the person’s MS
Specialists may be cautious in prescribing Sativex to people who:
• Are under 18 years of age due to lack of safety and efficacy data
• Have epilepsy or regular fits (seizures)
• Have liver, kidney or heart problems
• Are elderly, due to the increased risk of falls
• Have previously abused any drug or substance
• Are pregnant or plan to become pregnant. Sativex should not be used
unless the doctor believes the benefits of treatment outweigh the
Both men and women receiving Sativex should use effective contraception
during treatment and for three months after stopping Sativex.
10. Funding of Sativex
Sativex has not yet been assessed by NICE (the National Institute for Health
and Care Excellence) but is being included in the review of Clinical Guideline
8, Multiple sclerosis: management of multiple sclerosis in primary and secondary care. A decision is expected in 2014.
Until then, funding decisions are made locally by the relevant NHS authorities
according to local priorities and budgets. This means that funding is not
In areas where Sativex is not routinely funded, specialists may submit an
individual funding request (IFR) if they can make the case that the individual
will benefit. IFRs are not always granted, meaning that some people opt to
pay for Sativex themselves. The cost of fulfilling a private prescription varies
widely depending on the pharmacy so it is worth calling around for the best
In April 2011, the Scottish Medicines Consortium (SMC), which plays the
equivalent role to NICE for the NHS in Scotland, announced that it was unable
to recommend Sativex within the NHS in Scotland as it had not received a
submission from the holder of the marketing authorisation. However, an
individual patient treatment request (IPTR) can be made.
11. Travelling abroad with Sativex
Sativex is a controlled drug and its legal status varies between countries.
People taking Sativex should check its legal status in the countries to which
they are travelling by contacting the Embassy, Consulate or High Commission
of each country for information about the rules on carrying controlled drugs.
Driving while taking Sativex may be illegal in some countries.
People leaving the UK with Sativex will need a letter from their prescribing
• the name, total amount and strength of the medicine being carried.
They will not need a Home Office license if they are travelling for less than
three months or carrying less than three months supply of medicine.
Information on travelling abroad with Sativex is available at
When travelling through airport security, the current rules on carrying
medicines and carrying liquids will both apply.
12. Sativex for other symptoms and conditions
Sativex has also been studied for its effects on a number of other MS-related
symptoms including spasticity and spasms, pain, bladder symptoms9, tremor
and sleep disturbance. Sativex is still in development as a possible treatment
for cancer pain and neuropathic pain, including in MS. It is not licensed for
these uses as they are still experimental.
13. Legal position of Sativex and cannabis
Sativex was the first cannabis-based medicine to be licensed in the UK. It is a
class B drug and can only be lawfully possessed under a prescription issued
by a qualified health professional. Passing Sativex to someone else, unless
that person is lawfully entitled to possess the drug, amounts to unlawful
In contrast, 'street' cannabis is an illegal drug and is not currently recognised
in law as having any medicinal value. The penalties for possessing or using
cannabis are significant. Recent legal cases have indicated that the law
makes no exception for people using or supplying cannabis to help relieve
Cannabis and its derivatives are being tested in ongoing clinical trials. More
information is available on the MS Trust website in the 'cannabis' entry of the
A to Z of MS at www.mstrust.org.uk/atoz/cannabis
For further information on spasticity see the MS Trust’s Spasticity and spasms
factsheet. The Spasticity triggers resource is an aid to identifying factors that
can make spasticity worse. Both can be ordered on the MS Trust website at
www.mstrust.org.uk/pubs or by calling 0800 032 3839
1. Collin C, Ambler Z, Kent R, et al. A randomised controlled study of Sativex in patients
with symptoms of spasticity due to multiple sclerosis. In 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2006), Spain.
2. Collin C, Davies P, Mutiboko IK, et al. Randomised controlled trial of cannabis-based
medicine in spasticity caused by multiple sclerosis. European Journal of Neurology 2007; 14: 290-296.
3. Collin C, Ehler E, Waberzinek G, et al. A double-blind randomized placebo-controlled
parallel-group study of Sativex in subjects with symptoms of spasticity due to multiple sclerosis. Neurology Research 2010; 32(5): 451-459.
4. Novotna A, Mares J, Ratcliffe S, et al; the Sativex Spasticity Study Group. A randomized,
double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®) ), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. European Journal of Neurology 2011;18(9):1122-1131
5. Wade DT, Collin C, Stott C, et al. Meta-analysis of the efficacy and safety of Sativex
(nabiximols), on spasticity in people with multiple sclerosis. Multiple Sclerosis 2010;16(6):707-714.
6. Notcutt W, Langford R, Davies P, et al. A placebo-controlled, parallel-group, randomised
withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex ® (nabiximols). Multiple Sclerosis 2012;18(2):219-228
7. Robson P. Abuse potential and psychoactive effects of δ-9-tetrahydrocannabinol and
cannabidiol oromucosal spray (Sativex), a new cannabinoid medicine. Expert Opinion on Drug Safety 2011;10(5):675-685.
8. Aragona M, Onesti E, Tomassini V, et al. Psychopathological and cognitive effects of
therapeutic cannabinoids in multiple sclerosis: a double-blind, placebo controlled, crossover study. Clinical Neuropharmacology 2009;32(1):41-47.
9. Kavia RB, De Ridder D, Constantinescu CS, et al. Randomized controlled trial of Sativex
to treat detrusor overactivity in multiple sclerosis. Multiple Sclerosis 2010;16(11):1349-1359.
Please contact the MS Trust Information Team if you would like any further information about reference sources used in the production of this publication.
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