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

PARSIPPANY, N.J., Oct. 21, 2011 /PRNewswire/ -- On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 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 patients with painful osteoarthritis of the knee. Patients received three weekly injections of either EUFLEXXA or saline into the target knee. Following the double-blind portion of the trial, patients were offered to receive an additional three weekly injections of EUFLEXXA in a 26-week open-label safety extension. 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.

The number of patients reporting adverse events was generally similar between the EUFLEXXA and saline groups. The most common adverse events (>2%) reported in patients treated with EUFLEXXA were: arthralgia, hypertension, back pain, upper respiratory tract infection, diarrhea, injury and cough. In addition, results of the open-label extension demonstrated that repeated injection cycles of EUFLEXXA were well-tolerated up to 52 weeks. In this open-label portion of the study, the most commonly reported adverse events (>2%) were: arthralgia, nasopharyngitis, injury, back pain, joint swelling, upper respiratory tract infection and sinusitis.

"The results further support EUFLEXXA as the first bioengineered, non-avian, effective treatment option that provides osteoarthritis knee pain relief lasting up to six months. The labeling also reflects safety with repeated injection cycles," said Dr. Paul Korner, Senior Vice President,
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SOURCE Ferring Pharmaceuticals Inc.
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