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US Testing Begins for Marijuana Extract Sativex
Clinical study with the cannabis extract Sativex started for Cancer Pain
12-11-07|BBS News|Edited By Michael Hess

According to a press release by GW Pharmaceuticals the British company and its Japanese partner Otsuka Pharmaceutical began a phase III study of its cannabis spray Sativex pain-relief medicine for cancer patients. The five-week trial of 336 patients will test whether the drug reduces the pain of patients with advanced cancel who do not respond to opiates. The principal investigator of this study is Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. The study will be conductet in approximately 40 centers primarily in the US. The primary objective of the study is to evaluate the potential role and dose of Sativex in these patients as an adjunct to their pre- existing pain medications.

GW Pharmaceuticals plans to report first findings from the study next year and expects to receive U.S. regulatory approval in 2011. Otsuka has exclusive rights to develop and market Sativex in the U.S. GW Pharmaceuticals estimates, that as much as 40 percent of cancer patients have severe enough pain to warrant a treatment with opiates. Sativex is already approved in Canada for pain relief from advanced cancer and multiple sclerosis.

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