PecFent: Phase III data

A double-blind, placebo-controlled, crossover, international Phase III trial in 114 patients with breakthrough cancer pain showed that PecFent met the primary endpoint of a significantly improved mean SPID at 30 minutes vs. placebo (p<0.0001). PecFent also significantly improved pain intensity scores at 5 minutes (p<0.05).

PecFent met several secondary endpoints compared to placebo, including onset of effect, measured by time to >=1 point reduction in pain intensity, at 5 minutes (p<0.01), 10 minutes and 15 minutes (p<0.0001 for both); clinically meaningful reduction in pain intensity at 10 minutes (p<0.05); and SPID at 10 minutes (p=0.01) and at 15, 45 and 60 minutes vs. placebo (p<0.0001 for all). Clinically meaningful reduction in pain intensity is defined as >=2 point reduction in pain intensity. Most frequently reported adverse events were vomiting, nausea, disease progression and constipation. Data were published in Pain. ...