Sativex (nabiximols) does not meet primary endpoint in two Phase III trials to treat cancer pain- GW Pharma + Otsuka Pharma
GW Pharmaceuticals and Otsuka reported top-line results from the remaining two Phase III trials for the investigational product Sativex (nabiximols) in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimised chronic opioid therapy.
Consistent with the previously reported Phase III trial, nabiximols did not meet the primary endpoint in these trials. However, a pre-specified pooled analysis of patients across the two Phase III trials which involved clinical sites in the US showed a statistically significant improvement for nabiximols compared with placebo (p=0.024), with several secondary efficacy endpoints exhibiting p-values of less than 0.05. GW and Otsuka have submitted a request to meet with the FDA to discuss the clinical relevance of these data and to determine potential paths forward.
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