GW Announces Positive Preliminary Results with its Cannabis-based Medicine (Sativex®) in Phase III Cancer Pain Trial
GW Pharmaceuticals announces positive preliminary results in a Phase III clinical trial with Sativex® in 177 patients with severe cancer pain.
The trial was a multi centre, double-blind, randomised, placebo-controlled parallel group study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial.
The study included two different study medications - Sativex (a cannabis medicine containing tetrahydrocannabinol (THC) and cannabidiol (CBD)) and a THC-rich extract. Patients entering this three arm study were randomised equally to one of Sativex, THC extract or placebo. Each of these study medications were administered by means of a spray into the mouth.
In this Phase III trial, Sativex achieved a statistically significant improvement in comparison to placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that approximately 40% of patients on Sativex showed a greater than 30% improvement in their pain (p=0.024).
Analysis of escape medication, a second primary endpoint, showed that there were no significant changes in the use of escape medication. The improvements seen in pain were therefore attributable to the positive effects of Sativex.
The other active arm of this study, GW's THC extract did not show a significant effect in pain (p=0.24). This trial therefore suggests that Sativex is the more effective product for use in cancer pain.
In the trial, the adverse event data showed the medicines to be generally well tolerated.
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