What is DUROLANE?

DUROLANE is a single injection treatment to help relieve the pain of knee osteoarthritis (OA)2

It is based upon a natural, safe and proven technology called NASHA®. Hyaluronic acid (HA) is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint.

DUROLANE is a transparent gel which contains high levels of HA. It is injected into joints affected by osteoarthritis to relieve pain, which improves joint function and helps to restore quality of life. The stabilized form of HA in DUROLANE is known as NASHA.

The potential benefits of DUROLANE for OA sufferers include:


  • Directly treats the affected joint

  • Treatment is repeatable as required by your physician

  • May help to avoid or delay hip or knee replacement surgery

  • Long-term freedom from osteoarthritis pain

  • Simple & quick to administer

  • Drug-free alternative to pills

DUROLANE has been developed specifically as a single injection to treat the symptoms of OA.23


  • Advanced and unique NASHA technology8

  • History of safe use†

  • Longer lasting by design8,10

  • Significant and sustained benefits for OA patients1,12,13

* First introduced in the European Union in 2001.
† Over 1 million injections with low post marketing adverse event rate.


What is NASHA®?

DUROLANE is created using NASHA – an advanced patented process of hyaluronic acid (HA). It is a highly purified product produced without using any animal-sourced materials, ensuring that the risk of impurities is close to zero. DUROLANE is treated by the body in the same way as the body’s own hyaluronic acid and there have been no reported cases or instances of immunological or anaphylactic reactions.

DUROLANE is the only HA treatment for osteoarthritis (OA) that is based on NASHA. NASHA technology is the component of a number of medical products that use this unique HA and its properties to provide healthcare solutions.

 

NASHA is highly purified non-animal hyaluronic acid (HA)

NASHA_low-molecular-weight-HA.jpg
  • The process uses bacterial fermentation to obtain a high degree of purity of natural HA.

  • Potentially harmful components, such as proteins and endotoxins are minimised, and those of animal origin in particular, are excluded by the process.

  • The natural HA molecule forms a highly viscous gel due to the natural entanglement of the long chains of the molecule.

 

NASHA IS HIGHLY PURIFIED NON-ANIMAL HYALURONIC ACID (HA)

  • Standard cross-linking procedures insert a high ratio of chemical crosslinks along the HA molecular chain, resulting in HA formulations that are highly modified and non-physiological.

 

 

 

 

NASHA IS HIGHLY PURIFIED NON-ANIMAL HYALURONIC ACID (HA)

  • Because HA has a very short half-life in the body, molecular stabilisation is beneficial to increase residence time.
  • The stabilisation process of NASHA results in less than 1% modification of HA where covalent bonds are created to link the HA molecules together.8


How does DUROLANE work?

When you have osteoarthritis (OA), the hyaluronic acid (HA) in the synovial fluid in your joint becomes diluted and breaks down – reducing its natural properties.7 This is associated with increased inflammatory processes that can degrade the cartilage.7

This inflammation causes pain receptors to begin firing during normal movement.7 The pain tends to cause OA patients to limit movement which, in turn, contribute to further deterioration of joint structures and synovial fluid quality because movement is required for normal synovial activity. This process can become a vicious cycle as the disease becomes progressively worse and quality of life is severely compromised for patients.

DUROLANE is a single-injection treatment to relieve the pain of osteoarthritis in specific small and large joints.2 It is based upon a safe and proven technology of stabilised HA, NASHA®. HA is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint.


Are you the right candidate?

When you have osteoarthritis (OA), the hyaluronic acid (HA) in the synovial fluid in your joint becomes diluted and breaks down – reducing its natural properties.7 This is associated with increased inflammatory processes that can degrade the cartilage.7

  • Your pain is due to osteoarthritis
  • You are not getting adequate osteoarthritis pain relief from walking and/or physical therapy
  • You are not getting adequate osteoarthritis pain relief from pain medications, including:
    • Ibuprofen (e.g., Nurofen®)
    • Paracetamol (e.g. Panadol®)
    • Diclofenac (e.g. Voltaren®)

  • If you meet these criteria, ask your doctor if DUROLANE therapy is right for you!

Conversely, you should NOT receive DUROLANE therapy if you have infections or skin diseases in the area in which the injection will be given.

The safety and effectiveness of DUROLANE have not been established in pregnant women, lactating women, and children.

All trademarks are the properties of their respective companies.


Summary of indications for use in New Zealand

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee osteoarthritis.

There are no known contraindications.

You should not use DUROLANE if you have infections or skin disease at the injection site.

DUROLANE has not been tested in pregnant or lactating women, or children.

Risks can include transient pain, swelling and/or stiffness at the injection site.

DUROLANE is a Medsafe registered medical device and therefore does not require a prescription. However it should be administered by a suitably trained medical practitioner.

© 2015. Bioventus LLC. DUROLANE, Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. NASHA is a registered trademark of Galderma S.A.

 
  1. RPT-000374 Data on File MA 12414 – Report of Prior Clinical Investigations DUROLANE.
  2. DUROLANE Product Insert: 3ML (Dec. 2013) and SJ 1ML (Dec. 2013).
  3. Plaas A, Li J, Riesco J, Das R, Sandy JD, Harrison A. Intraarticular injection of hyaluronan prevents cartilage erosion, periarticular fibrosis and mechanical allodynia and normalizes stance time in murine knee osteoarthritis. Arthritis Res Ther. 2011;13(2):R46.
  4. Boettger MK, Kümmel D, Harrison A, Schaible HG. ‘Evaluation Of Long-Term Antinociceptive Properties Of Stabilized Hyaluronic Acid Preparation (NASHA) In An Animal Model Of Repetitive Joint Pain’. Arthritis Research & Therapy. 2011; 13.4: R110.
  5. Early Detection for OA. Arthritis Foundation Web site. http://www. arthritistoday.org/about-arthritis/types-of-arthritis/osteoarthritis/what-you-needto-know/biochemical-markers.php. Published 2015. Accessed January 28, 2015.
  6. American College of Rheumatology. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum.2000;43(9):1905­1915.
  7. Balazs EA, Denlinger JL. Viscosupplementation: a new concept in the treatment of osteoarthritis. J Rheumatol Suppl. 1993;39:3­9.
  8. Agerup B, Berg P, Åkermark C. Non-animal stabilized hyaluronic acid: a new formulation for the treatment of osteoarthritis. BioDrugs. 2005;19(1):23-30.
  9. Krocker D, Matziolis G, Tuischer J, et al. Reduction of arthrosis associated knee pain through a single intraarticular injection of synthetic hyaluronic acid. Z Rheumatol. 2006; 65(4):327-31.
  10. Edsman K, Melin H, Näsström J. A study of the ability of DUROLANE to withstand degradation by free radicals while maintaining its viscoelastic properties. Poster presented at: 55th Annual Meeting of the Orthopaedic Research Society; February 2009; Las Vegas, NV.
  11. Åkermark C, Berg P, Björkman A, Malm P. Non-Animal Stabilised Hyaluronic Acid in the Treatment of Osteoarthritis of the Knee A Tolerability Study. Clin Drug Invest 2002; 22 (3): 157-166.
  12. McGrath A, McGrath AM, Jessop ZM, et al. A Comparison of Intra-Articular Hyaluronic Acid Competitors in the Treatment of Mild to Moderate Knee Osteoarthritis. J Arthritis. 2013;2:1.
  13. Leighton R, Åkermark C, Therrien R, et al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial.Osteoarthritis Cartilage. 2014; 22: 17-25.
  14. Lindqvist U, Tolmachev V, Kairemo K, et al. Elimination of stabilised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41(8):603-613.
  15. Larsen NE, Dursema HD, Pollak CT, Skrabut EM. Clearance kinetics of a hylan-based viscosupplement after intra-articular and intravenous administration in animal models. J Biomed Mater Res B Appl Biomater. 2012; 100(2):457-466.
  16. Brown TJ, Laurent UB, Fraser JR. Turnover of hyaluronan in synovial joints: elimination of labelled hyaluronan from the knee joint of the rabbit. Exp Physiol. 1991; 76(1):125-134.
  17. Edsman K, Hjelm R, Lärkner H, et al. Intra-articular Duration of DUROLANE after Single Injection into the Rabbit Knee. Cartilage. 2011; 2(4) 384–388.
  18. Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 18;332(7542): 639- 42.
  19. Hinton R, Moody RL, Davis AW, Thomas SF. Osteoarthritis: Diagnosis and Therapeutic Considerations. Am Fam Physician. 2002;65(5):841-849.
  20. Wooley P, Song Z, Harrison A. Evaluation of the Biocompatibility of DUROLANE using the Murine Air Pouch Model. Poster presented at: 55th Annual Meeting of the Orthopaedic Research Society; February 2009; Las Vegas, NV.
  21. Berg P, Olsson U. Intra-articular injection of non-animal stabilised hyaluronic acid (NASHA) for osteoarthritis of the hip: a pilot study. Clin Exp Rheumatol.2004;22(3):300-6.
  22. Conrozier T, Couris CM, Mathieu P, et al. Safety, efficacy and predictive factors of efficacy of a single intraarticular injection of non-animal-stabilized-hyaluronicacid in the hip joint: results of a standardized follow-up of patients treated for hip osteoarthritis in daily practice. Arch Orthop Trauma Surg (2009) 129:843–848.
  23. Altman RD, Åkermark C, Beaulieu AD, Schnitzer T. Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee. OsteoArthritis and Cartilage. 2004; 12:642-649.
  24. Bannuru RR, Schmid CH, Kent DM, Vaysbrot EE, Wong JB, McAlindon TE. Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis. Ann Intern Med. 2015;162(1):46-54.