Take OA knee pain relief to another level
Take OA knee pain relief to another level
In a 12-week pivotal trial, maximum
pain relief was achieved with
10 weeks after the 3rd injection2,3*
Pain reduction began as early as 1-week
post-injection and improved with each
19% after injection 1 (n=160), 37% after injection
2 (n=159), and 48% after
injection 3 (n=159).2*
The most commonly reported adverse events in
this trial were arthralgia (14/160),
(8/160), and joint effusion (1/160).2
*Based on % reduction in WOMAC pain score from baseline in a
pivotal, 12-week trial of EUFLEXXA (n=157) vs Synvisc (n=158).
Pain-free defined as symptom-free for the 5 WOMAC pain
questions (with average visual analog scale [VAS] scores of <20 mm).2
†Primary endpoint: Mean change from baseline in 5 WOMAC pain
scores (noninferiority vs Synvisc). Synvisc
reduced OA knee pain by 55% (P<0.0001).2
‡Change from baseline in VAS (100-mm scale) for the average of 5
OA=osteoarthritis; VAS=visual analog scale; WOMAC=Western
Ontario and McMaster Universities Osteoarthritis Index.
Among patients with unilateral OA knee pain who avoided pain medication, 51% had received EUFLEXXA (n=34/67) vs 18% who had received Synvisc (n=13/72); P=0.0012*
In the overall population (unilateral and bilateral OA of the knee), ~44% more EUFLEXXA patients (62/159) avoided pain medication vs Synvisc patients (43/161); P=0.0132
*In a pivotal trial vs Synvisc; acetaminophen was the only rescue medication provided.2
In the FLEXX trial, the most common treatment
related adverse events were
back pain (12/293), and musculoskeletal pain
In the FLEXX extension, the most common
treatment related adverse events
(19/219), joint swelling (6/219), and back pain
*Primary efficacy outcome of the FLEXX trial based on the 50-foot
†Open-label extension study of the FLEXX trial (n=219) was not
designed to establish long-term efficacy of
a repeat injection series
*KL=Kellgren-Lawrence grading scale based on radiographical classification of knee osteoarthritis. KL-2
(n=235), KL-3 (n=353).
†In a post-hoc analysis of the FLEXX and FLEXX extension trials.
‡All numbers rounded to the nearest whole number.
In a pivotal trial, 1 effusion with EUFLEXXA (n=1, 0.6%) vs 15 effusions with Synvisc (n=13, 8.1%); P=0.0015.2
EUFLEXXA is not synthesized from avian protein
and has not been shown to cause pseudoseptic
reactions in clinical trials3
The most common adverse events were
arthralgia (11/160), back pain (1/160),
pressure increase (3/160), joint effusion
(1/160), joint swelling (3/160),
paresthesia (2/160), feeling of sickness of
skin irritation (1/160), and
tenderness in study knee (1/160)3
1. Rolling 12 month average of IQVIA claims data based on unique patients (August 2018-August 2019). 2. Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006;14(2):154-162. 3. EUFLEXXA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 4. Altman RD, Rosen JE, Bloch DA, et al. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX Trial). Semin Arthritis Rheum. 2009;39(1):1-9. 5. Altman RD, Rosen JE, Bloch DA, et al. Safety and efficacy of retreatment with a bioengineered hyaluronate for painful osteoarthritis of the knee: results of the open-label Extension Study of the FLEXX Trial. Osteoarthritis Cartilage. 2011;19(10):1169-1175. 6. Altman RD, Farrokhyar F, Fierlinger A, et al. Analysis for prognostic factors from a database for the intra-articular hyaluronic acid (Euflexxa) treatment for osteoarthritis of the knee. Cartilage. 2016;7(3):229-237.
EUFLEXXA® [1% sodium hyaluronate] is indicated for the treatment of pain in osteoarthritis [OA] of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics [eg, acetaminophen].
EUFLEXXA is contraindicated in patients who have a known hypersensitivity to hyaluronate preparations or who have knee joint infections, infections, or skin disease in the area of the injection site.
EUFLEXXA should not be administered through a needle previously used with medical solutions containing benzalkonium chloride. Do not use skin disinfectants for skin preparation that contain quaternary ammonium salts.
Do not inject intravascularly due to potential for systemic adverse events.
The safety and effectiveness of injection in conjunction with other intra-articular injectables, or into joints other than the knee have not been studied. Remove any joint effusion prior to injecting. Transient pain or swelling of the injected joint may occur after intra-articular injection with EUFLEXXA.
The most common adverse events related to EUFLEXXA injections reported in 12- and 26-week clinical studies were arthralgia, back pain, pain in extremity, musculoskeletal pain, and joint swelling. In an open-label extension of the 26-week clinical study with repeat series of injections, the most common adverse events related to EUFLEXXA at Week 52 were arthralgia and joint swelling.
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