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One in seven people testing Sativex failed to complete the treatment.
Among those who completed the clinical tests, the results were better, but under established protocols, regulators are required to take into account the drug’s success rate among all those who participate in the trial.
Sativex was granted a licence by the Canadian regulatory authority, April 2005, as
an add-
Although the drug is not licensed in the UK clinicians have been able to prescribe the drug on a ‘named patient basis’ a special if they consider it may be an appropriate treatment for any individual MS person.
Our own information from amongst our members indicates that Sativex has been a benefit to more than 55% of them.
Useful enough for MS sufferers to be given the opportunity to use and decide for themselves if it is of help.
A study paper published in ‘the Journal of Clinical Therapeutics’ indicates that Sativex provides an effective long term treatment for central neuropathic pain.
Side effects may occur:
Indicated as mild to moderate with no additional safety concerns.
Source: GW Pharmaceuticals Press Release.
Oct 17th 2007
Clinicians wishing to obtain further information about prescribing Sativex should contact:
Bayer Healthcare 01635 563 116
Comment.
Another potential beneficial treatment that the sufferer has to either pay for or fight to obtain.
A new phase 3 trial has begun designed to satisfy the regulators.
Results should be known by the end of 2008
The study follows a design which first identifies responders over a four week period (phase A),and then focuses on analysing the effect of Sativex vs placebo on those responders over a further 12 weeks (phase B)
Source
GW Pharma press release
Sativex as a treatment for Multiple Sclerosis apparently effective for pain, muscle spasms and depression.
For symptomatic relief only, does not affect the underlying condition.
Canadian Govt. has given approval for the treatment of pain and spasticity in MS patients.
A first for an unlicensed drug!
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a ‘public information report’ on Sativex
Their statement said that it considered it "in the interest of public health to provide potential prescribers with information on the MHRA's assessment of quality, safety and efficacy of Sativex in the relief of spasticity in people with muscular sclerosis" mhra.gov.uk/home
A canninoid derived oral spray developed for the treatment of MS-
2005 saw the approval of Sativex in Canada for use in controlling MS pain.
At the time GW Pharmaceuticals said “We remain committed to securing approval of Sativex across Europe and elsewhere.
In the UK results of a study in September 2005 indicated that Cannabis based Satives® significantly reduces Central Neuropathic Pain in people with Multiple Sclerosis.
In November 2005 the Home Office said the treatment could be imported to the UK for individual patient’s use on a Named Patient Basis.
However, problems arose over Primary Care Trusts throughout the country actually approving payments for the drug.
The year (2005) has ended with yet another “post code lottery” with regards to the availability of Sativex on the NHS.
In December GW Pharmaceuticals announced it had struck a deal with Spain’s Almirall to market Sativex in European countries excluding the UK.
There has been recent criticism of the drug following a trial which did not appear to show a clear benefit.
However the managing director of GW, blamed the disappointing results on volunteers who withdrew from the trials before they had been completed.
