cannabisnews.com: GW Clears Cannabis Hurdle GW Clears Cannabis Hurdle Posted by CN Staff on April 19, 2005 at 16:03:35 PT By Richard Irving Source: Times Online UK Drug regulators in Canada ushered in a new era in pain management yesterday when they approved a cannabis-based medicine for use in patients suffering from multiple sclerosis. The move, the first time that cannabis has been approved for use in a prescription drug, marks a significant breakthrough for GW Pharmaceuticals, the British company that has spent millions of pounds developing Sativex, an under- the-tongue spray made from cannabis plants, over the past six years. Shares in the AIM-listed company jumped 11˝p to 132˝p on hopes that British regulators, who are deliberating on the merits of the treatment, will take their lead from their Canadian counterparts and give the medicine the green light. An earlier attempt at drug approval in the UK was knocked back after the Medicines and Healthcare Products Regulatory Agency (MHRA) raised concerns over the way crucial test results were presented. However, the drug maker is appealing against the decision with the Medicines Committee, a senior advisory panel to the agency. The committee is expected to rule in the early summer on whether further trials are necessary. GW believes that Sativex can help to relieve several symptoms relating to MS, including neuropathic pain — pain in the nerve endings — muscle spasms and even sleep deprivation. The company has tested the spray on more than 1,500 volunteers and is about to start talks with US regulators over the steps it might need to take to secure approval in America. About 80,000 people suffer from MS in the UK. More than half of patients complain of severe pain, which can either occur spontaneously or be provoked by touch, movement or temperature fluctuations. Canadian authorities, which already allow MS sufferers to take unrefined cannabis to help to ease their suffering, had intimated that Sativex would be approved late last year and the company expects to launch the medicine in Canada within the next few weeks. Geoffrey Guy, GW’s executive chairman, said that he was optimistic that other regulators would follow the lead of those in Canada. “By the end of the decade we should be in all of the major markets around the world, with the possible exception of Japan,” he said. Dr Guy declined to forecast sales for the drug, which GW is marketing jointly with Bayer, the German pharmaceuticals giant. GW grows thousands of marijuana plants at a secret location in the English countryside, after special dispensation by the Government to grow the drug for medical research. GW’s dispute with the MHRA centres on whether the results of a recent trial are statistically relevant. If the Medicines Committee rules against GW, the company will have to conduct new trials. Dr Guy said that he was confident he could provide enough data to satisfy the committee’s concerns, clearing the way for a launch in the UK this summer. Source: Times Online (UK)Author: Richard IrvingPublished: April 20, 2005 Copyright: 2005 Times Newspapers Ltd.Contact: debate thetimes.co.uk Website: http://www.timesonline.co.uk/Related Articles & Web Site:GW Pharmaceuticalshttp://www.gwpharm.com/Cannabis Spray Gets Go-Ahead http://cannabisnews.com/news/thread20536.shtmlCanada Approves Pharma Drug in Cannabis Firsthttp://cannabisnews.com/news/thread20535.shtmlCanada Approves Cannabis Drug http://cannabisnews.com/news/thread20055.shtml Home Comment Email Register Recent Comments Help Comment #2 posted by runderwo on April 19, 2005 at 19:40:51 PT Yes Cannabis will have to be downgraded to Schedule II alongside less harmful substances (such as cocaine and heroin) in order for doctors to legally prescribe it. The message to our children will be the wrong one (that doctors should be able to help sick poeople) and people will start using cannabis recreationally (nobody currently does) if we do this. [ Post Comment ] Comment #1 posted by mayan on April 19, 2005 at 18:20:01 PT Hmmm... I still don't know if the U.S. government will ever appprove Sativex. If they do wouldn't they have to take cannabis off Schedule One? If they take cannabis off of Schedule One then the foundation of the entire drug war will quickly erode. Since they now have the "war on terror" to oppress Americans maybe they figure they won't have to sacrifice that much, if any power. Could it be that 9/11 and the subsequent war on terror were meant to be a substitute for when the inevitable death of the drug war occured...among other reasons(oil,transfer of wealth,permanent bases in middle east,etc.)? When the drug war ends(and it WILL end!) does anyone truly believe that the government will be any less intrusive into our lives? THE WAY OUT IS THE WAY IN...Theologian calls for response to 9/11: http://www.madison.com/tct/mad/local/index.php?ntid=36617Is America Preparing for Martial Law? http://globalresearch.ca/articles/CHO504B.htmlThe Secret World Of 9/11: http://www.scoop.co.nz/stories/HL0504/S00137.htm [ Post Comment ] Post Comment