The gist: A cancer pain drug called Sativex was not found to be any better than a placebo in a recent clinical trial. However, the makers of the drug are still optimistic about it, based on previous successful studies. They will continue to test it to see whether they can get better results.
“GW Pharmaceuticals plc and Otsuka Pharmaceutical Development & Commercialization, Inc., have reported the top-line results from the first of three Phase 3 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.
” ‘Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population’, stated Justin Gover, GW’s Chief Executive Officer. ‘We have two additional pivotal Phase 3 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.’ “