Comparative dosing

At the doses studied,* the co-crystal formulation has been shown to provide effective acute pain relief in appropriate patients with lower doses of each individual agent1,2

Comparative dosing chart Comparative dosing chart

The Phase 3 factorial study compared lower doses of the individual components of SEGLENTIS than are optimal for treatment of acute pain. The dosages of tramadol and celecoxib studied were not the maximum daily doses, rather they represented equivalent doses of the individual agents in the maximum daily dose of SEGLENTIS. This study is not suitable for making comparative efficacy claims.

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.

MME is an opioid dosage's equivalency to that of morphine. The MME-per-day metric is often used as a gauge of the overdose potential of the amount of opioid that is being given at a particular time.6

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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.
  3. Ultram (tramadol hydrochloride) tablets [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; September 2021.
  4. Opioid oral morphine milligram equivalent (MME) conversion factors. Utah Department of Health Medicaid. https://medicaid.utah.gov/Documents/files/Opioid-Morphine-EQ-Conversion-Factors.pdf. Accessed March 25, 2022.
  5. Celebrex (celecoxib) capsule [prescribing information]. New York, NY: Pfizer Inc.; May 2021.
  6. Centers for Disease Control and Prevention. Calculating total daily dose of opioids for safer dosage. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf. Accessed March 18, 2022.