A to Z of MS Sativex (nabiximols)

Sativex (nabiximols) is the first cannabis-based medicine to be licensed in the UK. In June 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) licensed Sativex for use as an add-on treatment for MS-related spasticity when people have shown inadequate response to other symptomatic treatments or found their side effects intolerable.

Sativex is formulated as a mouth (oromucosal) spray containing two chemical extracts derived from the cannabis plant: delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Cannabis plants are thought to contain more than 60 such chemicals - known as cannabinoids - but these two specific cannabinoids have been studied for their effects in MS.

Prior to gaining a licence for use in MS-related spasticity, Sativex had been studied for its effects on a number of MS related symptoms including: spasticity and spasms, pain, bladder symptoms, tremor, and sleep disturbance.

In 2009, a phase III trial investigating the effects of Sativex on MS spasticity was conducted in two stages. In the first stage, 573 people received Sativex for four weeks. The 241 people who responded to the drug went into the second stage where they received either Sativex or a placebo for 12 weeks. About three quarters of those receiving Sativex reported an improvement of greater than 30% in their spasticity score at least once during the first four weeks of treatment.

Side effects and contraindications

Side effects reported in the trials have included dizziness, drowsiness and a dry mouth. Sativex is not recommended for pregnant women and people under 18 years old. People with a history of psychotic problems should not take the drug.

Sativex may impair the mental and/or physical abilities required for certain potentially hazardous activities such as driving a car. People who experience any significant side effects should not drive, operate machinery or take part in any activity that could prove hazardous.

Being prescribed Sativex

Sativex can only be prescribed by a specialist doctor with experience of treating MS spasticity, for example: consultant neurologists, consultant rehabilitation specialists and consultant pain specialists. A specialist doctor will conduct a full assessment of the severity of spasticity related symptoms and an evaluation of the response to standard spasticity treatments for individuals who might benefit from the use of Sativex.

As Sativex has not been assessed by NICE, funding decisions are made locally by the relevant NHS authorities according to local priorities and this means that funding is not always available. In cases where the local NHS policy is not to fund the provision of Sativex, specialists may submit an individual funding request on behalf of their patients if they believe the drug will be of benefit to them.

In April 2011, the Scottish Medicines Consortium (SMC), which plays the equivalent role for the NHS in Scotland, announced that was unable to recommend Sativex as it has not received a marketing authorisation submission from the manufacturer.

MS Trust campaign for access to Sativex

No application for Sativex in Scotland - news item 14 April 2011

References

Novotna A, 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; Mar 1 [Epub ahead of print].
abstract

Kavia R, et al.
Randomized controlled trial of Sativex to treat detrusor overactivity in multiple sclerosis.
Multiple Sclerosis 2010; 16(11): 1349-1359.
abstract

Collin C, 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.
abstract

Collin C, et al.
Randomised controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.
European Journal of Neurology 2007; 14: 290-296.
abstract

Patient Information Leaflets

Sativex (EMC website)

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