On 19 October GW Pharmaceuticals and Bayer HealthCare announced that GW has submitted a regulatory application in Canada for their cannabis extract Sativex to seek approval for a new indication, for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.

According to the press release GW has completed a positive Phase III study in Europe in 177 patients with cancer pain. The trial was a multi-centre placebo-controlled study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication. In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial. Sativex achieved a statistically significant improvement in comparison with placebo in pain. 43 per cent of patients on Sativex showed a greater than 30 per cent improvement in their pain as measured on a numerical rating scale.

In 2005, Health Canada approved Sativex for the symptomatic relief of neuropathic pain in adults with multiple sclerosis. Canada became the first country in the world to approve Sativex.

More at: http://www.gwpharm.com/news_press_releases.asp?id=/gwp/pressreleases/currentpress/2006-10-19/

(Source: Press release by GW Pharmaceuticals of 19 October 2006)