• Stephen E Daniels, David Upmalis, Akiko Okamoto, Claudia Lange, and Jüergen Häeussler.
• Premier Research, Austin, TX, USA.
• Curr Med Res Opin. 2009 Mar 1;25(3):765-76.

ObjectiveThis study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery.MethodsThis randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomized patients (N = 603) received tapentadol IR 50, 75, or 100 mg; oxycodone HCl IR 15 mg; or placebo orally every 4-6 hours over a 72-hour period following bunionectomy. The primary endpoint was the sum of pain intensity difference (SPID) over 48 hours. Secondary endpoints included SPID over 12, 24, and 72 hours; total pain relief, and sum of total pain relief and sum of pain intensity difference (SPRID) over 12, 24, 48, and 72 hours; use of rescue medication; patient global impression of change; and onset of action assessment. Possible limitations of this study were that the intense dose monitoring and thorough nursing care were unlikely to represent actual use situations and could introduce similar bias across all treatment groups.Clinical Trial RegistrationNCT00364247.ResultsMean SPID(48) values were significantly higher for tapentadol IR (50, 75, and 100 mg) and oxycodone HCl IR 15 mg compared with placebo (all p ConclusionsMultiple doses of tapentadol IR (50, 75, and 100 mg) significantly relieve acute pain after orthopedic surgery compared with placebo. These data suggest that at doses providing comparable efficacy, tapentadol IR 100 mg has improved gastrointestinal tolerability compared with oxycodone HCl IR 15 mg.

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