Canada Approves GWs Cannabis Drug for MS Sufferers

Canada Approves GWs Cannabis Drug for MS Sufferers
Posted by CN Staff on April 19, 2005 at 17:12:36 PT
By Stephen Foley
Source: Independent UK
GW Pharmaceuticals has become the first drug company to gain approval to launch a cannabis-based medicine for multiple sclerosis sufferers.The approval in Canada comes after six years of work for the company, which grows cannabis at a secret farm in southern England and turns it into an under-the-tongue spray, Sativex. And it marks a breakthrough for MS sufferers, who have long argued that cannabis relieves its symptoms, including pain and spasticity.
The Canadian authorities will allow GW - through its marketing partner, the German drug giant Bayer - to sell Sativex as a prescription painkiller, provided the company does additional clinical trials of the medicine over the next five years. GW must confirm the results of the studies to date, which have been promising, Health Canada said. The drug has so far been turned down by regulators in the UK, who say GW has not proven to their satisfaction that Sativex is effective.Bayer will pay GW a 2m milestone as a result of Health Canada's approval. Launch batches of Sativex are already in the country, and the drug will be available within weeks. Analysts disagree on the likely sales potential in Canada, which has 50,000 MS sufferers, half of whom suffer from the neuropathic pain Sativex has been approved to treat. Smoked cannabis is also available in Canada for medicinal use, and proposals for its decriminalisation are being debated.Karl Keegan, an analyst at Canaccord, said: "I think initially there will be a lot of hype over Sativex, but I suspect that people will want to smoke cannabis rather than use a mouth spray."How Sativex is Seen: Canada: Health Canada has become the first regulator to approve a prescription medicine based on cannabis. Because so few MS sufferers say their pain can be treated effectively with existing medicines, it accelerated the approval process. UK: GW has faced several setbacks in its dealings with the UK, despite the Home Office's backing for its plans to develop a cannabis-based MS treatment. The independent medicines regulator argued there was not enough data to support its launch as a painkiller. GW is appealing the ruling at a hearing this summer. Europe: European regulators will take their cue from the UK, so analysts believe that Sativex's full commercial potential can only be unlocked when GW has satisfied the regulator in its home country. US: Originally thought opposed to cannabis-based medicines because it would represent weakness in its war on drugs. Now, though, GW believes regulators might be won round and will open talks this summer on how it might be allowed to trial Sativex in the US. Complete Title: Canada Approves GW's Cannabis Drug for Multiple Sclerosis SufferersSource: Independent (UK)Author: Stephen FoleyPublished: April 20, 2005Copyright: 2005 Independent Newspapers (UK) Ltd.Contact: letters  Related Articles & Web Site:GW Pharmaceuticals GW Clears Cannabis Hurdle Spray Gets Go-Ahead Approves Pharma Drug in Cannabis First
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Comment #2 posted by afterburner on May 07, 2005 at 09:16:25 PT
Off Topic, Sort of
Multiple Sclerosis (MS), for which cannabis is a useful medicine, has sometimes been linked to food allergies. The Toronto Star is running a special section on allergies & asthma, which some here may find interesting:The Toronto Star -Focus on allergies & asthma. 
"From the latest advances in medical technology and testing to the role schools have to play in helping children with breathing disorders, Star reporters bring you on special section addressing all the issues of concern to sufferers and their parents."13 Articles, so far.Of Special Note:The dirt on cleanliness
May. 5, 2005. 01:00 AM"Is there such a thing as being too clean? With allergies skyrocketing, some experts are beginning to ask that question."  [Full Story]
The Toronto Star - you know what to do
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Comment #1 posted by FoM on April 22, 2005 at 15:39:12 PT
Related Article from EDP News UK
Doctor Pioneers Cannabis-Based Drug By Stephen PullingerApril 21, 2005 For years people who have smoked cannabis to relieve chronic pain have lived in fear of possible arrest and prosecution.Now, thanks to the pioneering work of a Norfolk doctor, the beneficial effects of the plant  known for 5000 years  have been recognised in a legal medicine for the first time.Cannabis-based drug Sativex, developed in trials by consultant anaesthetist Dr William Notcutt at James Paget Hospital, Gorleston, has been licensed for use in Canada for patients suffering from multiple sclerosis (MS).Dr Notcutt, who started Britain's first clinical trial of cannabis as a medicine five years ago, welcomed the breakthrough but expressed disappointment the drug had yet to be sanctioned in this country.He said: "In the UK thousands of MS patients suffer from neuropathic pain. The condition is difficult to treat and, as a physician, I welcome any new treatment. "I have seen my patients benefit from Sativex in trials and it has an excellent safety profile. It is disappointing it is not yet available in the UK, particularly as we have done all the research and development."Canada has accepted the results of all the research and it says something about our regulatory authority that we are slower." He said many people were still using cannabis illicitly only to relieve their symptoms.Sativex, which is administered via a mouth spray, is the subject of a review by the UK regulatory authorities due for completion in the summer.Dr Notcutt, who began his trials five years ago, said they had initially been conducted on patients suffering from MS and spinal injuries, but he believed the treatment had even greater prospects.He believes it could be helpful with rheumatoid arthritis, and possibly in certain types of cancer, including brain tumours.He said: "There are lots of things coming out of the research, and in five or 10 years' time there could be an explosion of uses far beyond the world of pain."He used cannabis plants supplied by GW Pharmaceuticals specially grown for the purpose.Results were varied but some patients reported dramatic improvements, with two reporting "their best night's sleep for 10 years".Sativex is sprayed either under the tongue or on the inside of the cheek and is administered by the patient. Dr Notcutt said: "It is a very controlled form. "We can deliver the right dose to relieve spasms without causing light-headedness or drowsiness."Chris Jones, chief executive of the MS Trust , said: "It is good news for people with MS in Canada that they will now have the opportunity to test the effectiveness of cannabis treatment, using a product that is legal. "Clearly there are many people suffering with MS in the UK who will also be looking forward to the opportunity of finding out whether they also will benefit from this treatment." 
Copyright: 2005 Archant Regional
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