VIVLODEX® (meloxicam): The first low-dose SoluMatrix® meloxicam for osteoarthritis (OA) pain

VIVLODEX is a nonsteroidal anti-inflammatory drug (NSAID) indicated for management of OA pain.1

  • VIVLODEX is US Food and Drug Administration (FDA) approved at 5-mg and 10-mg doses administered once daily1
    • 5 mg is the lowest FDA-approved dose of meloxicam available2*
  • VIVLODEX may be appropriate for patients with OA pain who:
    • Are currently taking 15 mg of meloxicam per day and may benefit from a low-dose option
    • May benefit from a low-dose meloxicam

VIVLODEX 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

*For management of OA pain, the recommended starting dosage is 5 mg orally once daily. Dose may be increased to 10 mg in patients who require additional analgesia. The maximum recommended daily oral dose of VIVLODEX is 10 mg.

VIVLODEX® offers a unique pharmacokinetic profile1,5*

VIVLODEX provides rapid absorption5

  • VIVLODEX delivers low systemic exposure1,5,6*
  • VIVLODEX demonstrated early (within 2 hours) plasma levels1,5

Meloxicam plasma concentrations during the first 24 hours5*

This chart shows that VIVLODEX, a low dose meloxicam demonstrated early plasma levels.

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

*Based on a phase 1 study in healthy subjects.Although the 5-mg dose was not directly compared with meloxicam 15 mg, based on dose-proportional kinetics for VIVLODEX, the overall systemic exposure is 67% lower.

VIVLODEX® 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 5-mg dose was not directly compared with meloxicam 15 mg, based on dose-proportional kinetics for VIVLODEX, the overall systemic exposure is 67% lower.The LS mean for meloxicam 15 mg is 41,617.

VIVLODEX® delivers early Tmax1,5*

  • The median time to maximum plasma concentration (Tmax) occurred earlier for VIVLODEX capsules than for meloxicam tablets1,5

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

*Based on a phase 1 study in healthy subjects.Although the 5-mg dose was not directly compared with meloxicam 15 mg, based on dose-proportional kinetics for VIVLODEX, the overall systemic exposure is 67% lower.

VIVLODEX® 5 mg delivered impressive efficacy at low doses in patients with OA pain1,7*

Study Design: Randomized, double-blind, double-dummy, placebo-controlled study in 402 patients with clinically and radiographically confirmed hip or knee osteoarthritis.1,7

Primary end point: Change from baseline in WOMAC Pain Subscale Scores at week 121,7

Lower scores in this graph indicate greater reduction of OA pain with VIVLODEX 5 mg in a 12-week randomized, placebo-controlled clinical study.

Lower subscale scores indicate greater reduction of OA pain.

In a 12-week study, patients taking VIVLODEX 5 mg once daily experienced significant improvements in WOMAC Pain Subscale Scores compared with placebo.1,7

  • In the same study, VIVLODEX 5 mg once daily also demonstrated significant improvement in WOMAC Pain Subscale Scores at weeks 2 and 6

Secondary end point: Change from baseline in WOMAC Function and Stiffness Subscale Scores at Week 127

This graph shows additional data from VIVLODEX 5 mg clinical studies.

Lower subscale scores indicate greater improvement.

Patients taking VIVLODEX 5 mg also experienced significant improvements in WOMAC Function and Stiffness Subscale Scores at week 12.7

n based on ITT population.WOMAC=Western Ontario and McMaster Universities Arthritis Index.*For management of OA pain, the recommended starting dosage is 5 mg orally once daily. Dose may be increased to 10 mg in patients who require additional analgesia. The maximum recommended daily oral dose of VIVLODEX is 10 mg.

VIVLODEX® 10 mg delivered impressive efficacy at low doses in patients with OA pain1,7*

Study Design: Randomized, double-blind, double-dummy, placebo-controlled study in 402 patients with clinically and radiographically confirmed hip or knee osteoarthritis.1,7

Primary end point: Change from baseline in WOMAC Pain Subscale Scores at Week 121,7

This graph shows the results of VIVLODEX 10 mg in a 12-week randomized, placebo-controlled clinical study.

Lower scores indicate greater reduction of OA pain.

In a 12-week study, patients taking VIVLODEX 10 mg once daily experienced significant improvements in WOMAC Pain Subscale Scores compared with placebo.1,7

Secondary end point: Change from baseline in WOMAC Function and Stiffness Subscale Scores at Week 127

This graph shows additional data from VIVLODEX 10 mg clinical studies.

Lower scores indicate greater improvement.

Patients taking VIVLODEX 10 mg experienced significant improvements in WOMAC Function and Stiffness Scores at week 12.7

n based on ITT population.WOMAC=Western Ontario and McMaster Universities Arthritis Index.*For management of OA pain, the recommended starting dosage is 5 mg orally once daily. Dose may be increased to 10 mg in patients who require additional analgesia. The maximum recommended daily oral dose of VIVLODEX is 10 mg.

VIVLODEX® and rescue medication usage

Secondary end point: rescue medication usage over 12 weeks

This graph shows the rescue medication usage for VIVLODEX clincal trial over 12 weeks.

Rescue medication (acetaminophen 500 mg administered every 4 to 6 hours) was allowed as needed during the treatment period (maximum of 3000 mg per day).

n based on ITT population.LS mean=least squares mean.

VIVLODEX® was generally well tolerated in clinical trials1

In a 12-week phase 3 study in patients with OA pain, these adverse reactions occurred in ≥2% of patients treated with VIVLODEX and more frequently than with placebo1

Adverse reactionsVIVLODEX®
5 mg or 10 mg
(n=269)
Placebo
(n=133)
Diarrhea3%1%
Nausea2%0
Abdominal discomfort2%0

Long-term safety of VIVLODEX®1

Summary of adverse reactions (≥2%): 52-week, open-label study in patients with OA pain1

Adverse reactionsVIVLODEX® 10 mg
(n=600)
Arthralgia6%
Urinary tract infection6%
Osteoarthritis5%
Hypertension4%
Diarrhea4%
Headache4%
Upper respiratory tract infection4%
Back pain 4%
Nasopharyngitis4%
Bronchitis3%
Sinustits3%
Constipation3%
Dyspepsia3%
Nausea2%
Edema peripheral2%
Pain in extremity2%

Dosing and administration for VIVLODEX®

Available in low 5-mg and 10-mg doses1

  • VIVLODEX is FDA approved at 5-mg and 10-mg doses administered daily
    • 5 mg is the lowest FDA-approved dose of meloxicam available2*
  • VIVLODEX has no therapeutic equivalent1
*For management of OA pain, the recommended starting dosage is 5 mg orally once daily. Dose may be increased to 10 mg in patients who require additional analgesia. The maximum recommended daily oral dose of VIVLODEX is 10 mg.
VIVLODEX low dose meloxicam NSAIDs deliver lower systemic exposure compared to standard 15mg meloxicam.

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 VIVLODEX (meloxicam) capsules. Iroko Pharmaceuticals, LLC; 2015.
  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. Publ 5. 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. Hussaini A, Solorio D, Young C. Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults. Clin Rheumatol. 2016;35(4):1099-1104.
  6. Data on file, Iroko Pharmaceuticals, LLC.
  7. Altman R, Hochberg M, Gibofsky A, Jaros M, Young C. Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study. Curr Med Res Opin. 2015;31(12):2331-2343.