Other names: nabiximols
Sativex (nabiximols) is the first cannabis-based medicine to be licensed in the UK. The drug can prescribed for the treatment for MS-related spasticity when a person has shown inadequate response to other symptomatic treatments or found their side effects intolerable. Sativex can be used in addition to a person's current anti-spasticity medication.
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.
How is Sativex given?
Sativex is a mouth (oromucosal) spray containing two chemical extracts derived from the cannabis plant: delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). The number of sprays is gradually increased each day until the optimum dose is reached.
Side effects and contraindications
Common side effects include dizziness, drowsiness, diarrhoea, fatigue, nausea, headache 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.
Following changes introduced in March 2015, the Department of Transport has produced a leaflet to explain new drug driving rules for people prescribed Sativex (PDF, 302KB).
Being prescribed Sativex
Sativex can only be prescribed by a specialist doctor with experience of treating MS spasticity - consultant neurologists, consultant rehabilitation specialists and consultant pain specialists.
Use of Sativex is currently limited to those people who respond to the first four weeks of treatment. If there is no clear improvement in spasticity-related symptoms, treatment is stopped.
Sativex has not been fully assessed by NICE (the National Institute for Health and Care Excellence) as part of a separate technology appraisal. However, in the 2014 MS Clinical Guideline NICE did not recommend prescription of Sativex "because it is not a cost effective treatment".
In April 2011, the Scottish Medicines Consortium (SMC), which plays the equivalent role for the NHS in Scotland, announced that it was unable to recommend Sativex as it has not received a marketing authorisation submission from the manufacturer.
In August 2014, the All Wales Medicines Strategy Group (AWMSG) recommended that Sativex could be used within the NHS in Wales as a treatment for the symptoms of moderate to severe spasticity in people with MS.
- Expert Review of Neurotherapeutics. 2011; 11(5):627-637. Summary THC and CBD oromucosal spray (Sativex(®)) in the management of spasticity associated with multiple sclerosis.
- European Journal of Neurology 2011; 18(9):1122-1131. Summary 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.
- Multiple Sclerosis 2010; 16(11): 1349-1359. Summary Randomized controlled trial of Sativex to treat detrusor overactivity in multiple sclerosis.
- Neurology Research 2010; 32 (5): 451-459. Summary A double-blind randomized placebo-controlled parallel-group study of Sativex in subjects with symptoms of spasticity due to multiple sclerosis.
- European Journal of Neurology 2007; 14: 290-296. Summary Randomised controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.
Last updated: 18 March 2015
This page will be reviewed within three years