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FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
Date:10/21/2011

U.S. Development, Ferring Pharmaceuticals. "Ferring is committed to taking a leadership role in the research and development of osteoarthritis therapies. We are very pleased to provide ongoing scientific support and differentiation for EUFLEXXA and are gratified by the FDA approval."

About the Study: FLEXX Trial and FLEXX Trial Extension

The FLEXX trial enrolled 588 patients with osteoarthritis of the knee experiencing moderate to severe joint pain. Patients were randomized to either receive EUFLEXXA (n=293) or a saline control (n=295). At week 26, patients treated with EUFLEXXA had a -25.7 millimeter mean reduction in knee pain scores (based on a 100 millimeter visual analog scale) compared to a -18.5 millimeter mean reduction in knee pain scores for patients treated with the saline control injections. The group difference in least squares mean change from baseline of -6.6 millimeter (95% CI = -10.8 to -2.5 millimeter) was statistically significant (p-value = 0.002).

Following completion of the 26-week double-blind phase of the FLEXX trial, 433 patients continued on to the 26-week extension where they received three weekly EUFLEXXA injections (219 patients previously received EUFLEXXA and 214 patients previously received the saline control). The results of this open-label extension demonstrated that repeated injection cycles of EUFLEXXA were well-tolerated up to 52 weeks.

About EUFLEXXA (1% sodium hyaluronate)

EUFLEXXA is a bioengineered, non-avian product used to relieve osteoarthritis knee pain. It is used in people who do not get enough relief from simple pain medications such as acetaminophen or from exercise and physical therapy.

Important Safety Information

You should not receive this product if you have had any previous allergic reaction to EUFLEXXA or hyaluronan products. You should not have an injection into the knee if you have a knee joint infection or if you have a skin disease or i
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SOURCE Ferring Pharmaceuticals Inc.
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