In the first of three Phase III trials, the investigational marijuana-based drug Sativex did not meet its primary endpoint in demonstrating statistically significant difference from placebo for patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.
Despite these results, which were reported by GW and Otsuka Pharmaceuticals, there are still two additional Phase 3 trials that are ongoing.
The randomized, double-blind, placebo-controlled trial recruited 399 patients at clinical sites in the U.S., Mexico and Europe and evaluated the drug at 3 to 10 sprays over a 5-week period. There was an additional 5 to 14 stabilization period at the beginning of the trial as well as a one-week follow-up at the end.
While efficacy data wasn’t significant, U.S. sites showed more of a positive trend compared to non-U.S. sites, which was consistent with results from the Phase 2b trial. Sativex was well-tolerated in the patient population and the safety profile was consistent with previous studies.
“We believe that cannabinoid therapy offers a potentially novel approach as a co-analgesic to provide pain relief beyond opioid therapy,” said Marie Fallon, MD, of the University of Edinburgh and the principal investigator. “Whilst I am naturally disappointed that this first trial did not achieve its primary endpoint, I remain optimistic about the potential of Sativex and look forward to the upcoming data from the remaining Sativex Phase 3 trials later this year.”
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.