Euflexxa Labeling Updated to Include Extended Efficacy & Safety Data

The FDA has approved a labeling supplement for Euflexxa (sodium hyaluronate intra-articular injection; Ferring) to include 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles. The FLEXX trial was a 26-week multicenter, randomized, double-blind study evaluating the safety and efficacy of Euflexxa, compared with saline, in 588 patients with painful osteoarthritis of the knee. Results from the double-blind portion of the study showed patients treated with Euflexxa had a statistically and clinically significant decrease in osteoarthritis knee pain compared to those who received saline control injections as measured by a 50-foot walk test at week 26. In addition, results of the open-label extension demonstrated that repeated injection cycles of Euflexxa were well-tolerated up to 52 weeks.

Euflexxa is a bioengineered, viscoelastic hyaluronan indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (eg, acetaminophen).

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