New Drug Update 2009-2010 - LAFP

with placebo. Results are summarized in Table 3. A prespecified noninferiority comparison of tapentadol
75 mg with oxycodone 15 mg was also conducted; however, the 75 mg dose was not found to be
noninferior to oxycodone 15 mg as the lower boundary of the 2-sided 95% confidence interval exceeded
the prespecified noninferiority margin. A post hoc demonstrated noninferiority of tapentadol 100 mg with
oxycodone 15 mg (Curr Med Res Opin. 2009;25(3):765-776).
Table 3. Tapentadol vs Oxycodone in the Treatment of Postsurgical Bunionectomy Pain
Tapentadol
50 mg
(n = 119)
Tapentadol
75 mg
(n = 120)
Tapentadol
100 mg
(n = 118)
Oxycodone
15 mg
(n = 125)
Placebo
(n = 121)
Mean SPID12 23.2 a 30 a 35.5 a 35.6 a 4.7
Mean SPID24 46.6 a 60.5 a 73.3 a 73. 3a 5.2
Mean SPID48 119.1 a 139.1 a 167.2 a 172.3 a 24.5
Mean SPID72 207.9 a 230.5 a 271.1 a 288.3 a 55.7
Median time to perceptible
pain relief
Median time to meaningful
pain relief
≥ 50% reduction in
pain intensity at 48 h
Percentage rating overall
status “much improved” or
“very much improved”
Percentage receiving
rescue medication
Percentage reporting
adverse reactions
a P < 0.001.
46 min 31 min 36 min 30 min 34 min
2 h 1.75 h 1.5 h 1.3 h 4 h
58% 56.7% 70.3% 72.8% 30%
67% 77% 89% 88% 41%
19% 14% 10% 9% 49%
70% 75% 85% 87% 41%
Single-dose tapentadol immediate-release was also evaluated in a randomized, double-blind, placebocontrolled
study in patients with moderate to severe pain following mandibular third molar extraction. The
study enrolled 400 patients who were randomized to treatment with tapentadol 25, 50, 75, 100, or 200
mg, morphine sulfate 60 mg, ibuprofen 400 mg, or placebo. TOTPAR-8 was the primary end point.
TOTPAR-8 scores were greater for tapentadol 50, 75, 100, and 200 mg; morphine; and ibuprofen
compared with placebo; the greater effect with ibuprofen established the sensitivity of the model. The
study was not powered to detect differences between tapentadol and morphine. Results from this study
are summarized in Table 4 (Anesth Analg. 2008;107(6):2048-2055.)
Table 4. Single-Dose Study Using Tapentadol Immediate-Release to Treat Molar Extraction Pain
Tapentadol
25 mg
Tapentadol
50 mg
Tapentadol
75 mg
Tapentadol
100 mg
Tapentadol
200 mg
Morphine
60 mg
Ibuprofen
400 mg
Placebo
TOTPAR-8 6.3 7.9a 9.7a 11.6a 15.3a 13.8a 17.9a 4.7
Median time to
meaningful pain relief
8 h 8 h 8 h 3.9 ha 1.5 ha 2.6 ha 1.5 ha 8 h
≥ 50% pain relief 32.7% 46% 46% 64.6% a 87.8% a 64.7% a 76.5% a 25.5%
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