Tapentadol ER: Phase III data

In a double-blind, international Phase III trial in 1,030 patients, 100-250 mg twice-daily tapentadol ER significantly reduced average pain intensity from baseline to week 12 of the maintenance period vs. placebo, as well as throughout the entire 12-week maintenance period. The active control oxycodone CR significantly reduced average pain intensity from baseline throughout the maintenance period vs. placebo, but not at week 12. Furthermore, a significantly greater proportion of patients receiving tapentadol ER achieved a >=50% improvement in average pain intensity vs. placebo (32% vs. 24.3%, p=0.027), while a significantly lower proportion of patients receiving oxycodone CR achieved the endpoint (17.3%, p=0.023). Patients received tapentadol ER, oxycodone CR or placebo for a 3-week titration period followed by a 12-week maintenance period. Data were published in Clinical Drug Investigation. ...