Cancer Trials Review

In August 2007 GW announced the approval (NOC/c) in Canada of Sativex® as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.

GW has completed two Phase II trials with Sativex to date, details of which are provided below. A Phase III programme is now underway.

GW Sativex Cancer Pain Trials

A Phase II double-blind, randomised, parallel group, placebo-controlled trial in 177 patients with terminal cancer whose pain was not adequately controlled on existing strong opioid treatments (e.g. morphine).  For GW press release,click here.

Phase IIb randomized double-blind placebo-controlled parallel-group study recruited a total of 360 patients in 14 countries in North America, Europe, Latin America and South Africa, and evaluated three dose ranges of Sativex – a low dose (1-4 sprays per day), mid dose (6-10 sprays per day), and high dose (11-16 sprays per day) over a 5 week treatment period. For GW press release,click here.