Although the drug candidate, Oxytrex, did reduce physical dependency by 28% compared to an equivalent dose of oxycodone this result did not reach statistical significance due to high drop-out rates in all study arms.
The company anticipated that up to 40% of patients would drop-out before completing the study’s three-month treatment period. Actual drop-out rates were 48% to 60% in the drug arms and 37% in the placebo arm. The number of patients completing the study was lower than expected and, given the statistical rigor of the study design, statistical significance was not reached in the primary endpoint.
“We are highly encouraged by the promise of the science, however, in today’s trial we believe the signal was lost in the noise,” stated Dr Nadav Friedmann, chief operating and medical officer at Pain Therapeutics.