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Sativex for multiple sclerosis

Original article by: Alexandra Denby

Source: London New Drugs Group

Keywords: Sativex, cannabis, delta 9 tetrahydrocannabinol, THC, cannabidiol, CBD, delta-9-tetrahydrocannabinol, MS, multiple sclerosis

Date published: 14/06/2010 16:55

Summary
by: Alexandra Denby
  • Sativex is a cannabis-based medicine which contains delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in an oromucosal spray.
  • Currently Sativex is a Schedule 1 drug (with some restrictions lifted), but this is due to be changed when it is approved by the MHRA.
  • The regulatory submission for Sativex for the treatment of spasticity due to MS was filed in the UK in May 2009.
  • Sativex has been available on a named-patient basis in the UK since December 2005.
  • The trial data for the 2009 licence are not yet fully published: the data that are published do not given an indication of the clinical significance of the changes in symptoms seen with Sativex treatment, compared with placeob, or how the side effect profile compares with placebo.
  • 272 patients, classed as responders after an initial 4-week single-blind treatment phase, were randomised to treatment with either Sativex or placebo, in a 12-week double-blind phase. The mean change from pre-randomisation baseline in the spasticity numerical rating scale indicated a worsening with placebo treatment. The frequency of spasms occuring in the second phase were maintained with Sativex, but increased by ~2.5/day with placebo. 
  • A trial period of 4 weeks is required to assess response to Sativex: not all patients will respond.
  • There should be a 15 minute gap between sprays: for patients taking the average of 8 sprays a day (in 2 divided doses), administration will take one hour. 
Sativex_June_2010.pdf

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