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Canada poised to back cannabis painkiller
Mike Verdin The Times Online
Tuesday 21 Dec 2004 Canada is poised to become the first country to endorse a cannabis-based medicine after issuing final terms for the approval of a painkiller for multiple sclerosis patients. GW Pharmaceuticals said that it was poised to receive approval for its Sativex drug next year after receiving outline support from Health Canada, the country's healthcare regulator. Health Canada has issued a qualifying notice for Sativex, setting out terms on matters such as marketing, after which endorsement is considered a formality. "Under the Canadian system, full approval should be relatively straightforward from here," Jon Senior, the Evolution analyst, said. Full consent would make Sativex, which is derived from thousands of marijuana plants grown at a secret location in England, the first cannabis-based medicine approved for prescription, GW said. "This approval will be a major milestone for GW and for people with multiple sclerosis who have long awaited a prescription cannabis-based medicine for the treatment of neuropathic pain," Dr Geoffrey Guy, the GW chairman, said. He also praised the speed of the Canadian regulators, who have endorsed Sativex in seven months. "We are grateful to them for this rapid turnaround time," Dr Guy said. "Health Canada in their review reflects a welcome recognition of the clinical need in MS patients for Sativex." The comments come amid a prolonged drive by GW to win UK approval for Sativex, which was first submitted to British authorities in March last year. The Committee on Safety of Medicines earlier this month said that further study was needed to confirm that the drug was sufficiently beneficial for patients, meaning that Sativex will not be launched in Britain for at least six months. GW shares surged 10 per cent to 116p in early trade before dropping back to 114p, up 9p on the day.
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