Methods: To assess the analgesic efficacy and tolerability of tapentadol immediate release (IR) 50mg, tapentadol IR 100mg, and oxycodone HCl IR 10mg compared to placebo for relief of moderate-to-severe pain following bunionectomy, patients (N=268) were randomly assigned (1:1:1:1) to 1 of 4 treatment groups and received an oral dose every 4 to 6 hours over 3 days. Efficacy endpoint was summed pain intensity over 24 hours (SPI-24) on the second day after surgery based on a 4-point verbal rating scale. The study design was approved by an institutional review board at each site and all patients provided written informed consent before their enrollment.

Results: The mean [standard deviation] SPI-24 values for both doses of tapentadol (50mg, 33.6 [19.7], P=0.0133; 100mg, 29.2 [15.2], P=0.001) were significantly lower than placebo (41.9 [17.7]). In a separate analysis, oxycodone IR 10mg demonstrated a significant difference from placebo (35.7 [17.2], P=0.0365). The most common adverse events with tapentadol IR 50mg and 100mg, respectively, were nausea (46.3%, 66.2%), vomiting (16.4%, 35.3%), dizziness (32.8%, 64.7%), and somnolence (28.4%, 36.8%). The incidence of adverse events associated with oxycodone IR 10mg were nausea, 71.6%; vomiting, 38.8%; dizziness, 56.7%; and somnolence, 26.9%. Tapentadol IR 50mg and 100mg were associated with a lower incidence of constipation (6.0% and 7.4%, respectively) compared to oxycodone IR 10mg (17.9%).

Conclusions: These results demonstrate that tapentadol IR 50mg and 100mg are effective for relief of moderate-to-severe pain following bunionectomy. Tapentadol IR 50mg exerted similar efficacy compared to oxycodone HCl IR 10mg with an apparently improved tolerability profile.