The efficacy of SEGLENTIS was evaluated in a pivotal, Phase 3, randomized, double-blind, parallel-group study 
on acute pain after bunionectomy and osteotomy^1,2

Study details¹:

• Patients were randomized at a ratio of 2:2:2:1 to SEGLENTIS 200 mg every 12 hours, tramadol hydrochloride 50 mg every 6 hours, celecoxib 100 mg every 12 hours, or placebo in a double-blind, double-dummy study on acute pain after bunionectomy and osteotomy*
• The primary efficacy endpoint was time-weighted SPID48
• Patients in the SEGLENTIS group had significantly better LS mean SPID48 scores than any other group^†
• Use of rescue medication was permitted during the study. Rescue medication protocol:
  • First line—acetaminophen 1 g IV every 4 to 6 hours, not to exceed 4 g in 24 hours, and if not tolerated, or sufficient:
  • Second line—oxycodone 5 mg orally, every 4 to 6 hours, not to exceed 30 mg per day²
• Patients had a mean baseline pain intensity of 6.7 on the NPRS

ANCOVA, analysis of covariance; IV, intravenously; LS, least squares; NPRS, numeric pain rating scale; PO, orally; Q6H, every 6 hours; Q12H, every 12 hours; SPID48, sum of pain intensity difference over 48 hours.

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

^†LS means the P values were calculated from ANCOVA. Error bars represent 95% confidence interval.²

^‡The phase 3 factorial study compared lower doses of tramadol hydrochloride and celecoxib than the maximum for each individual agent for acute pain and, therefore, direct comparative claims cannot be made.²