The Canadian government announced Tuesday that a natural marijuana extract, which will be sold under the brand name Sativex, has won preliminary approval to be prescribed as a medicine in Canada. In a Qualifying Statement issued by Health Canada, the health agency said that all that remained was for GW Pharmaceuticals (http:///www.gwpharm.com), the British company that developed Sativex, to comply with certain conditions in order to market the drug. In a press release the same day, GW immediately signaled that those conditions were acceptable. A company spokesman said it would be "months, but not many months" before Sativex will be available for Canadian patients.
Sativex won initial approval for the treatment of neuropathic pain in multiple sclerosis patients. GW Pharmaceuticals said it hoped to win approval for its use for other conditions soon.
"We look forward to receiving final regulatory approval for Sativex in Canada in the early part of 2005," said Dr. Geoffrey Guy, GW executive chairman. "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. We view Canada as an important target market for Sativex. Sativex will be the first prescription cannabis-based medicine and we believe that the pragmatism shown by Health Canada in their review reflects a welcome recognition of the clinical need in MS patients for Sativex."
Health Canada's approval of Sativex prompted comment from Marijuana Policy Project executive director Rob Kampia, who ridiculed claims from the US drug-fighting establishment that marijuana could never be a safe and effective medicine. "This confirms that virtually everything the US government has told us about marijuana is wrong," said Kampia. "GW Pharmaceuticals has proven -- and the Canadian government has acknowledged -- that marijuana is indeed a medicine, one that is both effective and remarkably safe. This natural plant extract is nothing like Marinol, the THC pill sold in the United States, and GW's research shows conclusively that marijuana's medical benefits go far beyond THC."
"This product offers patients and doctors a new option, and Americans deserve access to it. The real lesson from this is that patients should have access to marijuana in whatever form they and their doctors find most useful," Kampia said. "Sativex is to marijuana as a cup of coffee is to coffee beans, and there is simply no justification for arresting patients for using different varieties of the same medication. In addition, marijuana in its natural form has significant advantages, including low cost and nearly instantaneous relief of symptoms."