Clinical Data

Efficacy

Demonstrated in a prospective, randomized, double-blind, multicenter, head-to-head study vs Synvisc®* (N=321)1

This was a prospective study, designed to show non-inferiority. Patients were centrally randomized to receive euflexxa® (n=160) or Synvisc® (n=161) in three 2 mL intra-articular injections administered at weeks 0, 1, and 2. Patients were assessed at screening visit and at baseline and weeks 1, 2, 3, 6, and 12.

Primary end point: mean change in visual analog scale (VAS: 0-100 mm) score on 5-question WOMAC Index pain subscale. Secondary end points: full WOMAC Index, patient global assessment, consumption of simple analgesics.

Reference: 1. 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. In press.

*Synvisc is a registered trademark of Genzyme Corporation.

euflexxa®:
Significantly Lower Incidence of Joint Effusions

Demonstrated in a prospective, randomized, double-blind, multicenter, head-to-head study vs Synvisc®* (N=321)1

Reference: 1. 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. In press.

*Synvisc is a registered trademark of Genzyme Corporation.

euflexxa®:
Significantly More Patients Reported Being Symptom-Free* at End of Study
Demonstrated in a prospective, randomized, double-blind, multicenter, head-to-head study vs SynviscR+ (N=321)1

Reference: 1. 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. In press.

*A patient was considered "symptom-free" when he or she scored less than 20 on the standardized pain scale of 0-100 mm.

+Synvisc is a registered trademark of Genzyme Corporation.

 
 euflexxa® success story from Oylmpic Hero, Bruce Jenner

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Important Treatment Consideration

euflexxa® (1% sodium hyaluronate) is indicated for the treatment of knee pain due to osteoarthritis (OA). It is used in people who have failed to get adequate pain relief either from simple pain medications, such as acetaminophen, or from exercise and/or physical therapy.

euflexxa® should not be used in people who have had any previous allergic reaction to hyaluronate preparations or who have knee joint infections or skin diseases in the area of the injection site.

In a randomized, double-blind, multicenter clinical trial, the only adverse event reported with euflexxa® at an incidence greater than 5% was arthralgia (joint pain) (8.75%). Temporary knee pain and swelling may occur after injection with euflexxa®.

The safety and effectiveness of injecting euflexxa® into the knee together with other injectable medications or into joints other than the knee have not been studied. The safety and effectiveness of treatment cycles of fewer than 3 injections or of repeated treatment cycles with euflexxa® have not been established. Strict aseptic technique must be followed to avoid joint infection.