By Telegraph reporters
13 Dec 2012
A review of evidence on the first licensed preparation, Sativex, said there were “limitations” which made it difficult to identify the place of the product in clinical practice.
However the makers of the drug said they believed the comments gave a misleading view and that the review writers appeared to have misunderstood important elements of trials.
Sativex, in the form of a mouth spray, contains the principal extracts – dronabinol and cannabidiol – found in the leaf and flower of the cannabis plant, and is the first cannabinoid preparation to be licensed for use in the treatment of muscle spasms in MS.
The review, in the December issue of Drug and Therapeutics Bulletin (DTB), published by BMJ Journals, says MS is estimated to affect around 60,000 people in England and Wales, and around one in every 1,000 people will develop the condition in the UK.
An increase in muscle tone, or spasticity, is a common symptom of the condition, causing involuntary spasms, immobility, disturbed sleep, and pain.
Complex combinations of drugs are sometimes needed to manage spasticity, but they do not work that well and have a range of unpleasant side-effects, the DTB says.
Sativex is intended for use as a second-line treatment in patients in whom these other options have failed. But the review said the trial data on which the success of Sativex is based are limited.
Overall, the trials, on which the drug’s approval was based, did show a small difference in the numbers of patients in whom symptoms abated compared with those taking a dummy (placebo) preparation, it said.
But in many of these studies, Sativex was used for relatively short periods – from six weeks to four months. And none included an active ingredient with which the effects of Sativex could be compared.
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