SEGLENTIS delivers effective acute pain relief ≤50 MME per day1,3

For appropriate patients with acute pain, SEGLENTIS tablets provide a treatment option with a lower MME,* at maximum daily dosages, than some commonly prescribed opioid analgesics1-3,7,8

MME provided by some commonly prescribed opioid analgesics at maximum daily dosages1-3,7,8†

SEGLENTIS is equivalent to less than half the MME (35.2 vs 80) of the maximum daily dose of tramadol hydrochloride alone in acute pain.1-3,9

SEGLENTIS contains a Schedule IV opioid, which is defined as having a low potential for abuse and low risk of dependence as compared with Schedule II or III opioids.1,6

 

 

SEGLENTIS provides significantly better acute pain relief at its lowest effective dose1

The combination of anti-inflammatory and analgesic effects of celecoxib with a Schedule IV opioid, tramadol hydrochloride, delivers significant pain relief vs either component alone1,2,6

SPID48 (primary efficacy endpoint)1,2*

The analgesic efficacy of SEGLENTIS was demonstrated in a pivotal Phase 3 trial involving patients with acute pain after bunionectomy and osteotomy.1,2

Pain intensity differences were reported on an NPRS and used to calculate the sum of pain intensity difference over 48 hours after bunionectomy and osteotomy.2

Immediate release co‑crystal formulation provides durable 12‑hour dosing1,5

SEGLENTIS tablets deliver pain relief with a less frequent dosing schedule than some commonly prescribed opioids1,7,8

Patients should take 2 tablets of SEGLENTIS every 12 hours as needed for acute pain. Each tablet contains 56-mg celecoxib and 44-mg tramadol hydrochloride (equivalent to 39-mg tramadol), equaling 224-mg celecoxib and 176-mg tramadol hydrochloride at the full dose of 4 pills daily.1,2

When initiating treatment with SEGLENTIS, keep in mind1

  • The patient’s severity of pain
  • Patient response
  • Prior analgesic treatment experience
  • Risk factors for addiction, abuse, and misuse

Important dosage and administration instructions1

  • Do not exceed the recommended dosage for SEGLENTIS
  • Do not coadminister SEGLENTIS with other tramadol- and celecoxib-containing products
  • Use SEGLENTIS for the shortest duration consistent with individual patient treatment goals
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy

Because SEGLENTIS contains tramadol, do not abruptly discontinue treatment in patients who may be physically dependent on SEGLENTIS.1

When initiating treatment with SEGLENTIS, keep in mind1

  • The patient’s severity of pain
  • Patient response
  • Prior analgesic treatment experience
  • Risk factors for addiction, abuse, and misuse

Important dosage and administration instructions1

  • Do not exceed the recommended dosage for SEGLENTIS
  • Do not coadminister SEGLENTIS with other tramadol- and celecoxib-containing products
  • Use SEGLENTIS for the shortest duration consistent with individual patient treatment goals
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy

Because SEGLENTIS contains tramadol, do not abruptly discontinue treatment in patients who may be physically dependent on SEGLENTIS.1

See how this co-crystal formulation works

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The efficacy of SEGLENTIS was evaluated in a pivotal, Phase 3, randomized, double-blind, parallel-group study 
on acute pain after bunionectomy and osteotomy1,2

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

References: 1. Seglentis [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021. 2. Viscusi ER, de Leon-Casasola O, Cebrecos J, et al. Celecoxibtramadol 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. 2023;23(1):8-22. doi:10.1111/papr.13136. Epub 2022 Jul 8. PMID: 35686380 3. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1 4. Almansa C, Frampton CS, Vela JM, Whitelock S, Plata-Salamán CR. Co-crystals as a new approach to multimodal analgesia and the treatment of pain. J Pain Res. 2019;12:2679-2689. doi:10.2147/JPR.S208082 5. Cebrecos J, Carlson JD, Encina G, et al. Celecoxib-tramadol co-crystal: a randomized 4-way crossover comparative bioavailability study. Clin Ther. 2021;43(6):1051-1065. doi:10.1016/j.clinthera.2021.04.002 6. United States Drug Enforcement Administration. Drug scheduling. Accessed March 28, 2023. https://www.dea.gov/drug-information/drug-scheduling 7. Hydrocodone bitartrate and acetaminophen tablets, USP 5 mg/300 mg, 7.5 mg/300 mg, 10 mg/300 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg [prescribing information]. KVK-Tech, Inc. August 2020. Accessed March 28, 2023. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f1063950-b302-4898-81c2-b1626c9c16ef&type=display 8. Oxycodone and acetaminophen tablets, USP CII [prescribing information]. Mayne Pharma Inc. December 14, 2022. Accessed March 28, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=205be197-5ad5-4849-bc78-5fda9927b531 9. Ultram (tramadol hydrochloride) tablets, for oral use, C-IV [prescribing information]. Janssen Pharmaceuticals, Inc.; February 2023. Accessed May 8, 2023. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ULTRAM-pi.pdf