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Ferring Euflexxa receives FDA approval

Labeling supplement for Euflexxa (1% sodium hyaluronate) by Ferring Pharmaceuticals has been approved by the US FDA, which has shown 26-week efficacy data from the Flexx trial and 52-week safety data to demonstrate the safety of repeated injection cycles.

Euflexxa is a bioengineered, non-avian product which provides relief from osteoarthritis knee pain, especially when simple pain medications such as acetaminophen or from exercise and physical therapy do not provide enough relief.

The 26-week multicenter, randomized, double-blind Flexx trial which enrolled 588 patients assessed the safety and efficacy of Euflexxa to treat osteoarthritis of the knee as compared to saline.

The study showed that patients treated with Euflexxa had a decrease in osteoarthritis knee pain versus saline control injections treated patients.