TIVORBEX® (indomethacin): The first low-dose SoluMatrix® indomethacin1

TIVORBEX is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain in adults.1

  • TIVORBEX 20 mg is the lowest dose of indomethacin available2
  • TIVORBEX is US Food and Drug Administration (FDA) approved at 20-mg and 40-mg doses1
    • Dosing: 20 mg TID, 40 mg BID or TID1
  • TIVORBEX is the second low-dose SoluMatrix® NSAID from Iroko Pharmaceuticals, LLC

TIVORBEX was developed to align with FDA recommendations on NSAID dosing: Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.3,4

TIVORBEX® offers a unique pharmacokinetic profile5*

Indomethacin plasma concentrations during the first 12 hours5

This chart shows that TIVORBEX, a lower-dose  indomethacin demonstrated early plasma levels comparable to indomethacin 50 mg.
  • TIVORBEX delivers low systemic exposure1,5,6
  • Both TIVORBEX 20 mg and 40 mg achieved comparable times to peak plasma levels as indomethacin 50 mg1,5
  • TIVORBEX provides early (within 1 hour) plasma levels, which ensures the drug is available for distribution to tissues1,5

The clinical relevance of the differences in pharmacokinetic measurements is unknown.

*Based on phase 1 study in healthy subjects.Although the 20-mg dose was not directly compared with indomethacin 50 mg, based on dose-proportional kinetics for TIVORBEX, the overall systemic exposure is 62% lower.

TIVORBEX® delivers low systemic exposure1,5,6*

The clinical relevance of the differences in pharmacokinetic measurements is unknown.

LS mean=least squares mean.*Based on a phase 1 study in healthy subjects.Although the 20-mg dose was not directly compared with indomethacin 50 mg, based on dose-proportional kinetics for TIVORBEX, the overall systemic exposure is 62% lower.The LS mean for indomethacin 50 mg was 7646.

TIVORBEX® 20 mg TID delivered impressive efficacy at low doses in patients with mild to moderate acute pain1,7

Study design: Randomized, multicenter, double-blind, active- and placebo-controlled parallel-group study comparing TIVORBEX 40 mg TID, 40 mg BID, 20 mg TID, and placebo in 462 men and women following bunionectomy.1

Primary end point: Summed pain intensity difference over 48 hours1,7

n based on ITT population.LS mean=least squares mean; VAS SPID=visual analog scale sum of pain intensity differences compared to baseline, measured by visual analog scale.

The baseline mean pain intensity was 73 (VAS 0-100) for the overall study population6:

  • TIVORBEX 20 mg TID provided a 43% reduction in pain intensity vs a 21% reduction for placebo at 12 hours
  • TIVORBEX 20 mg TID provided a 68% reduction in pain intensity vs a 48% reduction for placebo at 24 hours

TIVORBEX® 40 mg BID and TID delivered impressive efficacy at low doses in patients with mild to moderate acute pain1,7

Primary end point: Summed pain intensity difference over 48 hours1,7

Patients started with pain scores of 73 out of 1006:

  • TIVORBEX 40 mg TID provided a 48% reduction in pain intensity vs a 21% reduction for placebo at 12 hours
  • TIVORBEX 40 mg TID provided a 76% reduction in pain intensity vs a 48% reduction for placebo at 24 hours

TIVORBEX® was generally well tolerated in patients with mild to moderate acute pain1

Adverse reactions in ≥2% of patients and occurring more frequently than placebo in pooled safety population from 2 phase 3 trials in patients with postoperative pain1,6

Adverse reactionsTIVORBEX®
20 mg TID and 40 mg BID/TID
(n=554)
Placebo
(n=188)
Headache13%11%
Postprocedural bleeding7%6%
Pruritus3%0%
Diarrhea3%1%
Dyspepsia2%1%
Postprocedural swelling2%1%

Dosing and administration for TIVORBEX®

Available in low 20-mg and 40-mg doses1

TIVORBEX is an NSAID indicated for the treatment of mild to moderate acute pain in adults.1

  • TIVORBEX is FDA approved at 20-mg and 40-mg doses1
    • Dosing: 20 mg TID, 40 mg BID or TID1
  • TIVORBEX 20 mg is the lowest dose of indomethacin available2
    • TIVORBEX has no therapeutic equivalent1
  • TIVORBEX may be appropriate for patients with mild to moderate acute pain who
    • Are currently taking indomethacin and may benefit from a low-dose option
    • May benefit from a low-dose indomethacin
TIVORBEX indomethacin capsules for patients with mild to moderate acute pain

The FDA recommends that NSAIDs be used at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.3,4

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References

  1. Full Prescribing Information for TIVORBEX (indomethacin) capsules. Iroko Pharmaceuticals, LLC; 2016.
  2. US Food and Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations. http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm. Accessed August 1, 2016.
  3. US Food and Drug Administration. Public health advisory - FDA announces important changes and additional warnings for COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm150314.htm. Published April 7, 2005. Accessed August 1, 2016.
  4. US Food and Drug Administration. Drug safety communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm. Published July 9, 2015. Accessed August 1, 2016.
  5. Olugemo K, Solorio D, Sheridan C, Young CL. Pharmacokinetics and safety of low-dose submicron indomethacin 20 and 40 mg compared with indomethacin 50 mg. Postgrad Med. 2015;127(2):223-231.
  6. Data on file, Iroko Pharmaceuticals, LLC.
  7. Altman R, Daniel S, Young CL. Indomethacin submicron particle capsules provide effective pain relief in patients with acute pain: a phase 3 study. Phys Sportsmed. 2013;41(4):7-15.