23 November 2009 - UK-based cannabinoid pharmaceutical products developer GW Pharmaceuticals plc (LON: GPW) said today that results from a study of Sativex for the treatment of cancer pain have been published in the Journal of Pain and Symptom Management.

The company said that the authors of the paper conclude that "this study shows that Sativex is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids". Preliminary results from this study have previously been announced by the company.

The clinical study forms part of the ongoing development plan for Sativex in cancer pain, which represents the lead target indication for Sativex in the United States. A follow up Phase II/III cancer pain study is currently being carried out in collaboration with Otsuka Pharmaceutical Co Ltd, GW's US licensing partner for Sativex, with results due in Spring 2010.

The published multinational, randomised, placebo-controlled study included 177 patients with advanced cancer who had failed to gain adequate pain relief despite the use of strong opioids. This study compared the efficacy of Sativex (which comprises two cannabinoid extracts in which CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol) are the primary actives), a THC only extract formulation, and placebo.

The primary efficacy endpoint of the study was the difference in the mean improvement in pain scores between each of the active treatment groups and placebo. The results showed a significant improvement in the Sativex group compared with placebo (p=0.024). There was no significant improvement in the THC extract-treated group of patients compared with placebo. Overall, twice as many patients taking Sativex achieved a clinically meaningful improvement in their pain score of 30% or better compared with placebo (43% on Sativex vs 21% on placebo). The difference between the Sativex responder rate and that of placebo was highly statistically significant (p=0.006). The number of THC extract group responders was similar to placebo (23% vs. 21%). Most drug-related adverse events were mild/moderate in severity.

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