Porton Down, UK, 23 November 2009: GW Pharmaceuticals plc (GWP:AIM) announces that the results of a clinical study of Sativex® in the treatment of cancer pain have been published in the highly-regarded Journal of Pain and Symptom Management. 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 GW.
The Journal of Pain and Symptom Management is the Official Journal of the American Academy of Hospice and Palliative Medicine, the National Hospice and Palliative Care Organization, and the U.S. Cancer Pain Relief Committee. The Sativex paper is published online and will appear in the print copy of the Journal in the coming months1.
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 randomized 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.
Professor Marie Fallon, Professor of Palliative Medicine, University of Edinburgh, said, “These are very promising results for Sativex in an area where there is a real need for new approaches to treatment. A number of patients with advanced cancer are not able to gain adequate pain relief from the existing medications, and the prospect that a new treatment may become available will be good news for many people”.
Dr Stephen Wright, GW’s R&D Director, said: “This placebo-controlled study shows that Sativex provides meaningful pain relief for people with advanced cancer who are suffering pain not adequately relieved by strong opioids. Sativex consists of two cannabinoid extracts with CBD and THC as the primary components, and the fact that the comparative THC extract medicine was not effective in relieving pain provides good evidence of the benefits which the presence of CBD confers on Sativex. We continue to progress the development of Sativex in this important area of high unmet medical need.”
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Notes to Editors
Sativex is an investigational new product consisting of two extracts where CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol) comprise the primary cannabinoid components. Sativex is administered as a metered dose oro-mucosal spray, each 100µL spray contains 2.7mg THC and 2.5mg CBD. The Sativex formulation is standardized by both composition and dose and is supplied in small spray vials. The components of Sativex have been shown to bind to cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.
Sativex and Cancer Pain
Over one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Currently available opioid therapies do not yield sufficient relief in a substantial proportion of these patients and there is a clear need for new treatments.
Cancer pain is the lead indication for the development of Sativex in the United States. GW is now carrying out a 336 patient Phase IIb/III study in collaboration with its partner, Otsuka Pharmaceutical Co. Ltd., results from which are due in Spring 2010. Two further Phase III studies are planned prior to the submission of an NDA. Upon approval, Sativex will be exclusively marketed in the US by Otsuka. Cancer pain data generated as part of the US development programme for Sativex will also be used by GW for future regulatory submissions in this indication in Europe and elsewhere.
Sativex Marketing Partners
In Canada, Sativex is currently marketed by Bayer HealthCare. Once approved, Bayer will also market Sativex in the UK and Almirall has the rights for marketing in the rest of Europe. Upon approval in the US, Sativex will be marketed by Otsuka.
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.