Effective relief from osteoarthritis pain with one References

* Indications
safe treatment 7 - 1 0 The original
DUROLANE - Human 1
1. Lindqvist U et al. Elimination of stabilised hyaluronan from the knee joint in
70 healthy men. Clin Pharmacokinet 2002; 41: 603 13.
DUROLANE - Rabbit 4 2. Larsen NE et al. Clearance kinetics of a single injection cross-linked hylan-based DUROLANE (3ml): Symptomatic treatment of

single injection for

viscosupplement in a rabbit model. Osteoarth Cart 2007; 15(Suppl. C): C64.
60 Hylan G-F 20 3 x 2ml - Rabbit 2
3. Brown TJ et al. Turnover of hyaluronan in synovial joints: elimination of labelled mild to moderate knee or hip osteoarthritis. In
DUROLANE is a single-injection treatment to relieve the pain of osteoarthritis 50 1100KDa HA - Rabbit 3
hyalronan from the knee joint of the rabbit. Exp Physiol 1991; 76: 125-134.
4. Edsman K et al. Intra-articular duration of Durolane after single injection into
addition, DUROLANE has been licenced for the

osteoarthritis pain relief

symptomatic treatment associated with mild to

Hyaluronic acid (mg)

in joints of all sizes. It is based upon a safe and proven technology of stabilised 40
Hylan G-F 20 1 x 6ml - Rabbit 2
the rabbit knee. Cartilage April 11, 2011.
5. Wooley PH et al. Evaluation of the biocompatibility of Durolane using the moderate osteoarthritis pain in the ankle, fingers
hyaluronic acid, NASHA . Hyaluronic acid (HA) is a naturally occurring molecule
murine airpouch model. Poster presented at the 55th Annual Meeting of the
Orthopaedic Research Society, February 22-25, 2009; Las Vegas, Nevada, USA. and toes.
30
6. Boettger et al. Evaluation of long-term antinociceptive properties of stabilized
that provides the lubrication and cushioning in a normal joint. 20
hyaluronic acid preparation (NASHA) in an animal model of repetitive joint
pain. Arthritis Research & Therapy 2011, 13:R110.
DUROLANE SJ (1ml): Symptomatic treatment
7. Leighton, R. and N. Arden. A randomized blinded trial comparing one HA associated with mild to moderate osteoarthritis
10 injection to corticosteroid for knee osteoarthritis pain. Oral presentation #640 pain in the ankle, fingers and toes.
DUROLANE is a sterile, transparent viscoelastic gel supplied in either a 1ml or 3ml glass syringe with a luer-lok fitting, AAOS, 2010 New Orleans.
8. Conrozier, T. et al. Safety, efficacy and predictive factors of efficacy of a
packed in a blister pack. The contents of the syringe are sterile. 0
single intra articular injection of non-animal-stabilized-hyaluronic-acid in the Both DUROLANE and DUROLANE SJ are also
0 1 2 3 4 5 6 7 8
hip joint: results of a standardized follow-up of patients treated for hip indicated for pain following joint arthroscopy
DUROLANE contains 20mg/ml of stabilised, non-animal hyaluronic acid (NASHA) in buffered
Time physiological
(weeks) sodium osteoarthritis in daily practice. Arch Orthop Trauma Surg (2009) 129:843848.
9. Akemark C, Berg P, Bjrkman A, Malm P. Non-animal stabilised hyaluronic either in the presence of osteoarthritis or
chloride solution pH7. acid in the treatment of osteoarthritis of the knee. A tolerability study. Clin subsequent to general surgical repair within 3
Drug Invest 2002;22:157-66.
DUROLANE is a single dose preparation and should only be injected once per treatment course. 10. Altman RD, Akermark C, Beaulieu AD, Schnitzer T. Efficacy and safety of a months of the procedure.
single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA)

DUROLANE is indicated* for the symptomatic treatment of mild to moderate osteoarthritis.

in patients with osteoarthritis of the knee. Osteoarthritis Cartilage 2004;12:642649. There are no known contraindications. You
11. Plaas et al. Intraarticular injection of hyaluronan prevents cartilage erosion,
per articular fibrosis and mechanical allodynia and normalizes stance time in should not use DUROLANE if you have
murine knee osteoarthritisArthritis Research & Therapy 2011, 13:R46 infections or skin disease at the injection site.
12. Solayar GN et al. Intra-articular hyaluronic acid DUROLANE versus Bupivcaine
following knee arthroscopy. AAOS annual meeting 2011, poster presentation DUROLANE has not been tested in pregnant or
428, San Diego, California. lactating women, or children. Risks can include
A history of safe use 13. Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the
intra articular space of the knee. J Bone Joint Surg Am. 2002; 84:1522-1527 transient pain, swelling and/or stiffness at the
injection site.
Hylan G-F 20 DUROLANE

DUROLANE does not generate significant Antibody binding to viscosupplements As with any medical product, results cannot be
guaranteed and may vary depending on your
product specific antibodies 5 1000

Product Information individual medical condition. Please consult

800 your doctor for a complete description of the
Mice injected with different HA products under the skin advantages and potential adverse events of
Optical density 405 unit

PRODUCT CODE:
showed the following effects: 600 treatment with DUROLANE.
DUROLANE (3ml) 1082013
Antibody levels in DUROLANE treated animal blood
were no different to controls
400
DUROLANE SJ (1ml) 1082018
200
DUROLANE did not cause a systemic immune response

Antibody levels in Hylan G-F 20 treated animal blood 0.0

PBS DUROLANE Hylan G-F 20
were significantly greater than saline or DUROLANE

Hylan G-F 20 did stimulate a systemic immune response

DUROLANE - Human 1

Long lasting by design 1-4

70
DUROLANE - Rabbit 4

60 Hylan G-F 20 3 x 2ml - Rabbit 2

50 1100KDa HA - Rabbit 3
DUROLANE has a longer residence time in
Hyaluronic acid (mg)

the joint 1-4 40

Hylan G-F 20 1 x 6ml - Rabbit 2

30
Data from human and animal studies have shown that:
20

DUROLANE has a half life of four weeks in

the joint
10
DUROLANE
Bioventus Coperatief U. A.
The original single injection
0 Taurusavenue 31
DUROLANE provides a longer residence time
in a single injection treatment regime
0 1 2 3 4

Time (weeks)
5 6 7 8 2132 LS Hoofddorp
Netherlands
since
2001
Tel: 1-855-771-0606 (toll free)
Graphs based on elimination of HA from the joint space of rabbits 4 as a function
of time for DUROLANE as compared against extrapolated data for the residence
time of Hylan G-F 20 2 and low molecular weight HA 3 in a similar rabbit model. DUROLANE is a registered trademark of Q-Med AB.
NASHA is a trademark of Q-Med AB.
For full prescribing information,
DUROLANE values calculated based on projected clearance of one-3ml injection
(20mg/ml). Hylan G-F 20 values calculated based on projected clearance of one-6ml The Bioventus logo is a registered trademark of Bioventus LLC. visit our website.
injection (representing Synvisc-One) or three-2ml injections (representing Synvisc-3 2013 Bioventus LLC
injection regimen) of HA at 16 mg/ml in a rabbit model. 2 As seen above, DUROLANE
Human data correlates well with the rabbit model. 1
00000189
www.durolane.com
DUROLANE is advanced and unique Significant and sustained benefits for OA patients 7-10 Pre-clinical evidence for the efficacy of DUROLANE
NASHATM technology Effectiveness in comparision to corticosteroid DUROLANE prevented knee osteoarthritis progression in an animal model 11
DUROLANE is a stabilised, hyaluronic acid (HA)-based, viscoelastic gel for the A randomised, blinded trial comparing one HA injection to OA OA + HA
In an OA model:
intra-articular treatment of mild to moderate osteoarthritis of joints of all sizes. corticosteroid for knee osteoarthritis pain. n=8 n=8

HA injection protected joints from femoral

.04 .0002 .004 .0001 .0001
The pain relief effect of DUROLANE was shown to be non- 25 8 cartilage erosion as well as tibial and femoral
DUROLANE uses advanced and unique NASHA technology which gives it a unique gel particle structure. The patented inferior to methylprednisolone over 12 weeks. tissue fibrosis (see graph).
stabilisation technique ensures that the naturally cross-linked and entangled HA network is kept in place by introducing 20

Cartilage Erosion Score

6

a very limited number of synthetic cross-links, resulting in minimal modification. WOMAC pain scores were significantly improved in DUROLANE HA injection (but not saline injection) blocked

Fibrosis Score
15
patients compared to control patients at 26 weeks. 4 all OA gait changes.
10

One subset (n = 27) of patients showed the benefits lasted for Both HA injection and saline injection reduced
2

nine months.
5 pain, but the HA effect was more pronounced
and prolonged than the saline injection.
NASHA structure 0
Tibial
Plateau
Femoral
Condyle
Patellar
Groove
0
Tibial
Plateau
Femoral
Condyle
Patellar
Groove

Joint Tissue Pathology Scores showing the protective effects of prophylactic hyaluronan (HA) on murine joint osteoarthritis (OA). (a) Cartilage erosion
Entanglement of HA chains scores and (b) fibrosis scores for the OA (n = 8) and OA + HA (n = 8) groups illustrates the statistically significant and area-specific effects of HA on
(natural cross-links) murine OA pathology.

Synthetic cross-links Effectiveness in hips NASHA provided superior pain relief in an animal knee joint pain model 6
Significant improvements at six months following injection under 260 NASHA was compared to other HA preparations* and a saline

Mechanical Thresholds injected knee [g]

fluoroscopic control: 8 control:
240
Forty patients with hip OA were treated with a single intra The saline control was least effective at pain relief shown by
Stabilised HA: 1% stabilisation forms a flexible molecular network which resists physiological catabolism.1 articular injection of DUROLANE. 220
the least amount of pressure applied to the knee joint after
200 injection to induce a response.
Walking Pain, Patient Global Assessment, WOMAC A & B
decreased significantly between baseline and six months. 180 The pain relief NASHA provided was significantly better than
unmodified sodium hyaluronate and Hylan GF20 at multiple
71% were classified OMERACT-OARSI responders. 160 time points (* p<0.05: ** p<0.01)
140 A single injection of NASHA provided pain relief out to 56 days
0 in this animal knee pain model
BL 1 7 14 28 56
Days after treatment

NASHA Hylan GF20 Sodium NaCl

hyaluronate

Primary mechanical pain threshold was assessed following an injection of pain inducing agents by ascending pressure applied to the animal knee joint,
after a single injection of NASHA (50 l, n = 11), Hylan GF20 (100 l, n = 9), and sodium hyaluronate (33 l, n = 11). Although saline-treated animals
showed a dramatic drop in mechanical thresholds from day 1, all hyaluronic acid compounds showed antinociceptive properties. These were most
Clinical support for the use of DUROLANE post-arthroscopy 12 pronounced for NASHA and Hylan GF20, which were superior to unmodified sodium hyaluronate, particularly in the later stages.

* Preparations used included: NASHA (DUROLANE), Hylan GF20 (Synvisc) and unmodified sodium hyaluronate (Hyalgan).
In a randomised, double-blind trial comparing DUROLANE to bupivacaine (n=98) NOTE: Clinical dosage of Hyalgan is three or five injections. Model utilizes single injection.

DUROLANE was observed to be as effective as Bupivacaine in the immediate post-operative period and first six
Clinicians using a lateral midpatellar extended-leg injection technique reported the most accurate (93%) approach for
weeks following surgery.
intra-articular needle placement in a knee with no effusion.13
Patients with grade III-IV chondral defects that received DUROLANE reported significantly lower VAS pain
scores at rest and movement at all time points.