Sativex sublingual cannabis extract spray: Preliminary Phase IIb data

Preliminary data from a double-blind, international Phase IIb trial in 360 patients showed that all 3 doses of Sativex missed the primary endpoint of a significantly greater proportion of patients experiencing a pain reduction of >=30% as measured by NRS scores vs. placebo. However, in a continuous response analysis, which is an analysis of all responders characterized by percent improvement, low- and mid-dose Sativex significantly improved pain scores vs. placebo (p=0.008 and p=0.038, respectively). GW said that the continuous response analysis has been "the key efficacy parameter discussed in the product labeling of several recently approved medicines for pain" in the U.S., such as Lyrica pregablin from Pfizer Inc. (NYSE:PFE, New York, N.Y.) and Cymbalta duloxetine from Eli Lilly and Co. (NYSE:LLY, Indianapolis, Ind.). Low-dose Sativex also significantly improved average NRS pain scores from baseline vs. placebo (p=0.006). Furthermore, low-dose Sativex met the secondary endpoint of significantly reducing sleep disruption vs. placebo (p=0.003). ...