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Canada Approves Cannabis Medication Sativex® For Use By Multiple Sclerosis Patients

GW Pharma's stock rose in mid-April 2005 on news that the Canadian government had given approval for the company's new drug Sativex® to be used by multiple sclerosis patients. The Toronto Globe & Mail reported on April 19, 2005 ( "Cannabis Spray Gets Go-Ahead") that "Canada is the first country in the world to approve a cannabis spray that relieves pain in people with multiple sclerosis, Health Canada said Tuesday. The announcement sent shares of the U.K. maker of the drug, GW Pharmaceuticals Plc, up as much as 14 per cent in London. Bayer AG will market the drug in Canada. Sativex®, which is administered through a spray in the mouth, relieves pain in patients that suffer from MS, the government agency said. It's expected to hit the shelves by late spring."

According to the Globe & Mail, 'Effective pain control and management are extremely important in a disease like MS,' said Dr. Allan Gordon, neurologist and director of the Wasser Pain Management Centre at Mount Sinai Hospital in Toronto, in a statement. 'The approval of Sativex® in Canada reflects the urgent need for additional treatment options in the field of neuropathic pain in MS.' Neuropathic pain, or nerve pain, is a common symptom of MS and can occur in as many as 86 per cent of people with the disease, Health Canada said. The drug is derived from two compounds, delta-9- tetrahydrocannabinol and cannabidiol."

The Independent newspaper reported on April 19, 2005 ( "Canada Approves GW's Cannabis Drug For Multiple Sclerosis") that "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."

According to the Independent, "Bayer will pay GW a UKP2m 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.'"

For general information on Canada's medical cannabis policies, check out Health Canada's Office of Cannabis Medical Access.

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