EUFLEXXA reduces OA knee pain2

A well-controlled, 12-week pivotal clinical trial supports the benefit of a 3-injection regimen

The primary endpoint measured noninferiority* in effectiveness between EUFLEXXA and Synvisc.


*This study was powered to test for noninferiority of EUFLEXXA as compared to Synvisc.
Improvements from baseline were statistically significant for both treatment groups.
Change from baseline in VAS (100-mm scale) for the average of 5 WOMAC scores.
VAS=visual analog scale; WOMAC=Western Ontario and McMaster University Osteoarthritis Index.

Mean improvements in pain from baseline as measured by 5 WOMAC pain scores (noninferiority)*

  • 62% (29.9 mm) EUFLEXXA vs baseline (P<0.0001)
  • 55% (28.4 mm) Synvisc vs baseline (P<0.0001)
EUFLEXXA and Synvisc were given in a 3-dose series
Mean improvements in pain from baseline as measured by 5 WOMAC pain scores (noninferiority)

  • 62% (29.9 mm) EUFLEXXA vs baseline (P<0.0001)
  • 55% (28.4 mm) Synvisc vs baseline (P<0.0001)
EUFLEXXA and Synvisc were given in a 3-injection regimen
Please See Important Safety Information and Full Prescribing Information.

INDICATION

EUFLEXXA® [1% sodium hyaluronate] is indicated for the treatment of pain in osteoarthritis [DA] of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics [eg, acetaminophen].

IMPORTANT SAFETY INFORMATION

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.

Please see Full Prescribing Information.

Please see Full Prescribing Information.