Iroko products help health care professionals and patients across the world manage pain in a responsible manner.

Iroko offers innovative medications to help patients manage their pain. Specifically, Iroko has developed and commercialized three low-dose nonsteroidal anti-inflammatory drugs (NSAIDs) that were created using SoluMatrix Fine Particle Technology™. These new low-dose SoluMatrix® NSAIDs include meloxicam, diclofenac, and indomethacin, three of the most widely used NSAIDs worldwide.1

Iroko low-dose NSAIDs are in alignment with recommendations issued by FDA and echoed by regulatory authorities, professional medical organizations, and advocacy groups to use NSAIDs at the lowest effective dose for the shortest duration. These authorities and organizations include:

  • American College of Cardiology2
  • American Heart Association2
  • American College of Rheumatology3
  • National Kidney Foundation4
  • American Gastroenterological Association5
  • European Medicines Agency6
  • National Institute for Health and Care Excellence7
  • Health Canada8
  • England’s National Health Service9
  • NHS Greater Glasgow and Clyde Area Drug and Therapeutics Committee10

 

Iroko Pharmaceuticals low-dose SoluMatrix® NSAIDs

  • FDA recommends that NSAIDs be used at the lowest effective dosage for the shortest duration consistent with individual treatment goals11
  • The risk of serious GI, CV, and renal adverse events associated with NSAID use are dose related and can occur in as little as 1 week following initial dosing12-20
  • SoluMatrix Fine Particle Technology™ is a proprietary technology that Iroko uses to create NSAIDs at low-dose strengths with rapid absorption and low systemic exposure21-23
  • Iroko low-dose SoluMatrix® NSAIDs were developed to align with FDA and regulatory authorities as well as leading medical organization recommendations on NSAID dosing.1-11,24

In addition, in the United States, Iroko offers INDOCIN® (indomethacin) oral suspension and INDOCIN® suppositories as alternatives to tablets or capsules.

Outside of the United States, Iroko, along with its partners, markets and distributes INDOCID® (indomethacin) suppositories, INDOCID® sustained release (SR) capsules, and INDOCID® immediate release (IR) capsules, as well as ALDOMET® (methyldopa) tablets.

References:

  1. Data on file, Iroko Pharmaceuticals, LLC.
  2. 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.
  3. 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 Rheumatol. 2008;59(8):1058-1073.
  4. National Kidney Foundation. Pain medicines (analgesics). https:/www.kidney.org/atoz/content/painMeds_Analgesics. Accessed March 4, 2016.
  5. American Gastroenterological Association, Wilcox CM, Allison J, Benzuly K, et al. Consensus development conference on the use of nonsteroidal anti-inflammatory agents, including cyclooxygenase-2 enzyme inhibitors and aspirin. Clin Gastroenterol Hepatol. 2006;4(9):1082-1089.
  6. European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/11/WC500014477.pdf. Published September 26, 2006. Accessed June 26, 2013.
  7. National Institute for Health and Care Excellence (UK NICE). http://www.nice.org.uk/CG059. Published February 2008. Accessed June 26, 2013.
  8. Health Canada. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/nsaid-ains/nsaids_ains-eng.php. Published November 23, 2006. Accessed June 26, 2013.
  9. National Health Service. http://www.wirral.nhs.uk/document_uploads/Disclosure-Feb2010/776-NSAIDsguidelinesDraftV2Nov09(2).pdf. Published November 23, 2009. Accessed August 12, 2016.
  10. NHS Greater Glasgow and Clyde. http://www.ggcmedicines.org.uk/media/uploads/ps_extra/postscript_extra_-_nsaids_may_14_final_for_web.pdf. Published May 2014. Accessed August 12, 2016.
  11. US Food and Drug Administration. Public health advisory – FDA announces important changes and additional warnings for COX-2 selective and non-selective nonsteroidal anti-inflammatory drugs (NSAIDs). http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm150314.htm. Published April 7, Accessed December 4, 2015.
  12. Castellsague J, Riera-Guardia N, Calingaert B, et Safety of Nonsteroidal 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.
  13. McGettigan P, Henry Cardiovascular risk with nonsteroidal anti-inflammatory drugs: systematic review of population based controlled observational studies. PLoS Med. 2011;8(9):e1001098.
  14. 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.
  15. Coxib and traditional NSAID Trialists’ (CNT) Collaboration; Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of nonsteroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382(9894):769-779.
  16. García Rodríguez LA, Tacconelli S, Patrignani 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.
  17. García Rodríguez LA, Hernández-Díaz S. Relative risk of upper gastrointestinal complications among users of acetaminophen and nonsteroidal anti-inflammatory drugs. Epidemiology. 2001;12(5):570-576.
  18. Schneider V, Levesque LE, Zhang B, Hutchinson T, Brophy JM. Association of selective and conventional nonsteroidal anti-inflammatory drugs with acute renal failure: a population-based, nested case-control analysis. Am J Epidemiol. 2006;164(9):881-889.
  19. Helin-Salmivaara A, Virtanen A, Vesalainen R, et 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.
  20. 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 Scand J Gastroenterol. 2007;42(8):923-932.
  21. Hussaini A, Solorio D, Young C. Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults. Clin Rheumatol. [epub ahead of print].
  22. Desjardins PJ, Olugemo K, Solorio D, Young CL. Pharmacokinetic properties and tolerability of low-dose SoluMatrix diclofenac. Clin Ther. 2015;37(2):448-461.
  23. 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.
  24. 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 December 4, 2015.