Efficacy demonstrated in the
Phase 3 clinical trial

SEGLENTIS demonstrated statistically significantly better summed pain intensity difference over 48 hours (SPID48) than tramadol hydrochloride, celecoxib, and placebo1

The efficacy and safety of SEGLENTIS were evaluated in a pivotal, Phase 3, randomized, double-blind, parallel-group study comparing SEGLENTIS to tramadol hydrochloride, celecoxib, and placebo.1

Study details1:

SPID48‡2

In this trial, pain intensity differences were reported on an NPRS and were used to calculate the sum of pain intensity difference over 48 hours after the procedure.1,2

Total daily dose: 400 mg of SEGLENTIS (2x 56-mg celecoxib/44-mg tramadol hydrochloride tablets, twice a day), 200 mg of tramadol hydrochloride (50 mg 4 times a day), 200 mg of celecoxib (100 mg twice a day), or placebo 4 times a day.

LS means and P values calculated from ANCOVA. Error bars represent 95% confidence interval.

The Phase 3 factorial study compared lower doses of the individual components of SEGLENTIS than are optimal for treatment of acute pain, and this study is not suitable for making comparative efficacy claims.

P value is the estimate of the difference between the LS mean of SEGLENTIS versus the LS mean of the other treatment groups. ANCOVA analysis, full analysis set.

Pain intensity difference (PID) by evaluation time point from baseline to 48 hours—postoperative bunionectomy with osteotomy (full analysis set population)‡1

The Phase 3 factorial study compared lower doses of tramadol and celecoxib than are optimal for treatment of acute pain, and this study is not suitable for making comparative efficacy claims.

In an exploratory analysis of secondary endpoints‡||

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At 4 hours, LS mean SPID scores for the SEGLENTIS group were -5.1 vs celecoxib (-2.7) and placebo (-0.18).¶2

At 6 hours, LS mean SPID scores for the SEGLENTIS group were -8.1 vs tramadol hydrochloride (-5.1) and placebo (-0.34).¶2

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LS mean PID scores at 1 hour were -1.4 for the SEGLENTIS group vs celecoxib (-0.80) and placebo (-0.50).#2

LS mean PID scores at 1.25 hours were -1.5 for the SEGLENTIS group vs celecoxib (-0.80) and placebo (-0.45).#2

LS mean PID scores at 3.5 hours were -1.5 for the SEGLENTIS group vs tramadol hydrochloride (-0.95) and placebo (-0.27).#2

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Median time to onset of analgesia was 1.1 hours with SEGLENTIS and 6.5 hours with tramadol hydrochloride.2

ANCOVA, analysis of covariance; IV, intravenously; LS, least squares; MMRM, mixed model for repeated measures; NPRS, Numeric Pain Rating Scale; SPID, summed pain intensity difference.

The Phase 3 factorial study compared lower doses of the individual components of SEGLENTIS than are optimal for treatment of acute pain, and this study is not suitable for making comparative efficacy claims.

No formal statistical inferences were drawn from secondary efficacy analyses. These data points should be interpreted with caution, and in an exploratory sense only, and did not include any adjustment for multiplicity or additional sensitivity analyses.

ANCOVA analysis of full set population.

MMRM analysis of full set population.


See how SEGLENTIS performed in a Phase 3 clinical trial

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References

  1. SEGLENTIS [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021.
  2. Viscusi ER, de Leon-Casasola O, Cebrecos J, et al. Celecoxib‐tramadol co‐crystal in patients with moderate‐to‐severe pain following bunionectomy with osteotomy: a phase 3, randomized, double‐blind, factorial, active‐ and placebo‐controlled trial. Pain Pract. 2022;00:1-15. doi:10.1111/papr.13136.