ZORVOLEX® is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the management of mild to moderate acute pain or OA pain.1

  • ZORVOLEX is indicated for management of mild to moderate acute pain at low dosages (18 mg TID and 35 mg TID)1
    • ZORVOLEX 54 mg per day (18 mg TID) is the lowest effective daily dosage for diclofenac1,2
  • ZORVOLEX is indicated for management of OA pain at a dosage of 35 mg TID1

The Science of Less: Low-Dose SoluMatrix® NSAIDs

ZORVOLEX was the first low-dose SoluMatrix® NSAID from Iroko Pharmaceuticals, LLC. Iroko developed SoluMatrix® NSAIDs 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

  • Professional medical organizations and advocacy groups—including the American College of Cardiology, American College of Rheumatology, and National Kidney Foundation—also recognize the importance of using the lowest effective dosage for the shortest duration of time5-7

The US Food and Drug Administration (FDA) continues to monitor and evaluate the safety of NSAIDs, resulting in the dissemination of a Public Health Advisory (2005) and a Drug Safety Communication (2015).3,4

Professional medical organizations and advocacy groups also recognize the importance of using the lowest effective dosage for the shortest duration aligned with individual patient treatment goals.

  • American College of Cardiology5
  • American College of Rheumatology6
  • National Kidney Foundation7
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    In 2005, FDA required manufacturers of all marketed prescription NSAIDs to revise the labeling for their products to include a Boxed Warning and a Medication Guide3:

    • The Boxed Warning highlighted the potential for increased risk of cardiovascular (CV) events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use
    • FDA recommended the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
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    Iroko Pharmaceuticals, LLC was founded to address an unmet need in the practice of analgesia: Low-dose NSAIDs that align with FDA recommendations on NSAID dosing.

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    In July 2015, FDA strengthened the Boxed Warning to include statements that non-aspirin NSAIDs increase the chance of a heart attack or stroke.4 The FDA is requiring all manufacturers of all prescription non-steroidal anti-inflammatory drug (NSAID) pain relievers - including medications like ibuprofen (Motrin®), celecoxib (Celebrex®), and naproxen (Naprosyn®) – to include updated safety language within their product labels.

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    Starting in May 2016, prescription NSAID labels now reflect the following information:

    • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID
      • The risk may increase with longer use of the NSAID
    • The risk appears greater at higher doses
    • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease
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The risk of serious cardiovascular, gastrointestinal, and renal adverse events (AEs) associated with NSAID use has been shown to be dose related.8-13 Even short-term NSAID therapy places patients at risk: Serious AEs can occur in as little as 1 week following initial dosing.10,14,15

The majority of prescriptions for meloxicam, diclofenac, and indomethacin are written at the highest-approved daily dose.16

Increased the risk of cardiovascular events by

28% 13
compared to low-medium doses

Increased the risk of upper GI complications by

104% 11
compared to low-medium doses

Increased the risk of acute renal failure by

35% 10
compared to low-medium doses
  • With SoluMatrix Fine Particle Technology, Iroko Pharmaceuticals, LLC has engineered NSAID treatments that delivered effective pain relief at low doses1,17,18
  • SoluMatrix® NSAIDs deliver early plasma levels with low systemic drug exposure19-21
  • Low-dose SoluMatrix® NSAIDs were developed to align with dosing recommendations from FDA, professional medical organizations, and advocacy groups3-7, 22

Low-Dose SoluMatrix® NSAIDs

SoluMatrix Fine Particle Technology is used to create NSAID drug particles that are approximately 10 to 20 times smaller than their original size.16

  • This reduction in particle size increases surface area, which leads to the product being quickly dissolved and rapidly absorbed
Fine drug particles created by SoluMatrix Fine Particle Technology are compared with their original sizes in this image.
Fine drug particles created by SoluMatrix Fine Particle Technology are compared with their original sizes in this image.

See SoluMatrix Fine Particle Technology in action

Watch a video that illustrates how SoluMatrix Fine Particle Technology works.

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ZORVOLEX is an NSAID indicated for the management of mild to moderate acute pain or OA pain.1

  • ZORVOLEX is indicated for management of mild to moderate acute pain at low dosages (18 mg TID and 35 mg TID)1
    • ZORVOLEX 54 mg per day (18 mg TID) is the lowest effective daily dosage for diclofenac1,2
  • ZORVOLEX is indicated for management of OA pain at a dosage of 35 mg TID1
  • ZORVOLEX was the first low-dose SoluMatrix® NSAID from Iroko Pharmaceuticals, LLC

VIVLODEX meloxicam capsules for osteoarthritis pain treatment

ZORVOLEX:

  • Delivers low systemic exposure1,20
  • Delivered impressive efficacy at low doses1,23,24
  • Was generally well tolerated in patients with mild to moderate acute pain or OA pain in clinical trials1
  • Most common adverse reactions (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, and dyspepsia1
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References

  1. Full Prescribing Information for ZORVOLEX (diclofenac) 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. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007;50(7):e1-e157.
  6. American College of Rheumatology Ad Hoc Group on Use of Selective and Nonselective Nonsteroidal Antiinflammatory Drugs. Recommendations for use of selective and nonselective nonsteroidal antiinflammatory drugs: an American College of Rheumatology white paper. Arthritis Rheum. 2008;59(8):1058-1073.
  7. National Kidney Foundation. Pain medicines (analgesics). Available from: https://www.kidney.org/atoz/content/painMeds_Analgesics. Accessed August 1, 2016.
  8. Castellsague J, Riera-Guardia N, Calingaert B, et al. Safety of Non-Steroidal Anti-Inflammatory Drugs (SOS) Project. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012;35(12):1127-1146.
  9. McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLOS Med. 2011;8(9):e1001098.
  10. Huerta C, Castellsague J, Varas-Lorenzo C, García Rodríguez LA. Nonsteroidal anti-inflammatory drugs and risk of ARF in the general population. Am J Kidney Dis. 2005;45(3):531-539.
  11. Garcia-Rodriguez LA, Hernandez-Diaz S. Relative risk of upper gastrointestinal complications among users of acetaminophen and nonsteroidal anti-inflammatory drugs. Epidemiology. 2001;2(5):570-576.
  12. Coxib and traditional NSAID Trialists’ (CNT) Collaboration, Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382(9894):769-779.
  13. García Rodríguez LA, Tacconelli S, Patrignani P. Role of dose potency in the prediction of risk of myocardial infarction associated with nonsteroidal anti-inflammatory drugs in the general population. J Am Coll Cardiol. 2008;52(20):1628-1636.
  14. Helin-Salmivaara A, Virtanen A, Vesalainen R, et al. NSAID use and the risk of hospitalization for first myocardial infarction in the general population: a nationwide case-control study from Finland. Eur Heart J. 2006;27(14):1657-1663.
  15. Helin-Salmivaara A, Saarelainen S, Grönroos JM, Vesalainen R, Klaukka T, Huupponen R. Risk of upper gastrointestinal events with the use of various NSAIDs: a case-control study in a general population. Scand J Gastroenterol. 2007;42(8):923-932.
  16. Data on file, Iroko Pharmaceuticals, LLC.
  17. Full Prescribing Information for VIVLODEX (meloxicam) capsules. Iroko Pharmaceuticals, LLC; 2015.
  18. Full Prescribing Information for TIVORBEX (indomethacin) capsules. Iroko Pharmaceuticals, LLC; 2016.
  19. Hussaini A, Solorio D, Young C. Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults. Clin Rheumatol. 2016; 35(4):1099-1104.
  20. Desjardins PJ, Olugemo K, Solorio D, Young CL. Pharmacokinetic properties and tolerability of low-dose SoluMatrix diclofenac. Clin Ther. 2015;37(2):448-461.
  21. 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.
  22. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartil. 2008;16(2):137-162.
  23. Gibofsky A, Silberstein S, Argoff C, Daniels S, Jensen S, Young C. Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study. Postgrad Med. 2013;125(5):130-138.
  24. Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014;30(9):1883-1893.