Study Shows EUFLEXXA(R) Patients Report Significant Improvements in Osteoarthritis of the Knee Pain over a Six Mo...( Results of FLEXX Trial Presented ...),Health

Results of FLEXX Trial Presented at the Osteoarthritis Research Society International's 2008 World Congress

PARSIPPANY, N.J., Oct. 7 /PRNewswire/ -- Ferring Pharmaceuticals Inc. recently presented results from the FLEXX Trial of Osteoarthritis of the Knee, showing that EUFLEXXA(R) (1% sodium hyaluronate), a highly pure non-avian high molecular weight form of intra-articular hyaluronic acid (IA-HA), is superior to intra-articular saline (IA-saline) for the relief of pain in knee osteoarthritis (OA) at 26 weeks. The results of the trial of 586 patients were presented in a poster at the Osteoarthritis Research Society International 2008 World Congress in Rome, Italy. "The study results clearly demonstrate that EUFLEXXA rapidly relieved the pain of knee osteoarthritis and that effect was sustained at the six-month period," said Dr. Roy D. Altman, MD, a FLEXX Trial investigator.

About the Study

In the 26-week randomized, saline-controlled, double-blind study, 586 patients were evaluated prior to and following three weekly intra-articular injections of IA-hyaluronan (n=291) or buffered IA-saline (n=295). The demographics of the hyaluronan group were: age 62.5 (plus or minus) 10.6, 63% women, BMI 32 (plus or minus) 7, Kellgren-Lawrence Grade 2-41%, Grade 3-59%, initial pain 56 (plus or minus) 22, with minimal differences in the IA-saline group.

After 26 weeks, patients treated with IA-hyaluronan showed a significant improvement in pain after the 50-foot walk compared to those in the IA-saline group (p = 0.004). Secondary variables generally supported the primary measurement. Serious adverse events occurred in IA-hyaluronan (n=10) and IA-saline (n=9) groups. Arthralgia occurred in IA-hyaluronan (n=27) and IA-saline (n=35) groups.

About EUFLEXXA

EUFLEXXA (1% sodium hyaluronate) is the first non-avian derived hyaluronic acid approved in the U.S. for the treatment of pain caused by knee osteoarthritis and is indicated for a th
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