GW and Otsuka report Sativex failed to meet primary endpoint in cancer pain

UK-based GW Pharmaceuticals (AIM: GWP) and Japanese drug maker Otsuka (TYO: 4768) have reported that Sativex (nabiximols) did not meet the primary endpoint in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.

Shares of GW were trading down more than 13% to $61.56 in this morning’s premarket after the companies reported the top-line results from the first of three Phase III trials for the investigational product Sativex in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. In this first trial, Sativex (as adjunctive treatment to optimized chronic opioid therapy) did not meet the primary endpoint of demonstrating a statistically significant difference from placebo.

Justin Gover, GW’s chief executive, said: “Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase II program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population. We have two additional pivotal Phase III trials ongoing which, if positive, would still allow us to submit a New Drug Application with the US FDA. We look forward to results from these two further studies later this year.”