The US subsidiary of Ferring Pharmaceuticals presented the results of a six-month safety and efficacy study, demonstrating that Euflexxa (1% sodium hyaluronate) was effective at decreasing the pain of knee osteoarthritis compared to saline after 26 weeks, at the annual meeting of the American Academy of Orthopedic Surgeons, held in Las Vegas, Nevada.
The multicenter, 26-week, randomized, double-blind trial compared Euflexxa and intra-articular buffered saline for level of pain following a 50-Foot Walk Test, measured by 100 mm visual analog scale. The 586 patients with chronic idiopathic knee OA were randomized to treatment with either product in a 1:1 ratio. Each patient received one weekly injection for three weeks with nine follow-up visits over 26 weeks after the first injection.
The Euflexxa group showed an advantage over saline in pain reduction, with a larger mean decrease from baseline in pain scores: -25.7 (28.9) mm versus -18.5(32.5) mm respectively, with a least squares means of -6.6mm (p=0.002). At 26 weeks, 145 (58%) of Euflexxa subjects reported a greater than or equal to 20-mm improvement in pain based on the VAS scoring, compared with 120 (46%) in the other group (p=0.006). The percentage of Osteoarthritis Research Society International responders for the Euflexxa group was also significantly greater than that in the control group (67% vs 59% (p=0.047).
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