Results Show Superior Decrease in Pain Scores Compared to Saline
PARSIPPANY, N.J., May 13 /PRNewswire/ -- Ferring Pharmaceuticals recently presented the results of a six-month safety and efficacy study demonstrating that EUFLEXXA(R) (1% sodium hyaluronate) was effective at decreasing the pain of knee osteoarthritis (OA) at 26 weeks. The study showed that EUFLEXXA (R) is superior to saline in decreasing pain at 26 weeks in patients with OA of the knee.(1) The study results were presented by Dr. Roy D. Altman in a poster at the Annual Meeting of the American Academy of Orthopedic Surgeons on February 23, 2009.
EUFLEXXA(R) is a three-injection treatment regimen indicated for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. The goal of hyaluronic acid (HA) therapy is to reduce pain and improve physical function by replenishing the HA in human synovial fluid (fluid in joints). In OA, this fluid becomes thinner, leading to a decrease in elasticity and viscosity.
About the Study
The multicenter, 26-week, randomized, double-blind trial compared EUFLEXXA(R) and intra-articular buffered saline (IA-SA) for level of pain following a 50-Foot Walk Test, measured by 100 mm visual analog scale (VAS). 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 3 weeks with 9 follow-up visits over 26 weeks after the first injection.
The EUFLEXXA(R) 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 -6.6 mm (P=0.002). At 26 weeks, 145 (58%) of EUFLEXXA(R) 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 (OARSI) responders for the EUFLEXXA(R) group was also significantly greater than that in the other group (67% versus 59% (P=0.047). A subject is considered a responder if there is a high improvement in pain or function, or improvement in at least two of the following three categories: pain greater than or equal to 20% and absolute change greater than or equal to 10 mm, function greater than or equal to 20% and absolute change greater than or equal to 10 mm, and/or patient global assessment greater than or equal to 20% and absolute change.
EUFLEXXA(R) (1% sodium hyaluronate) is the first non-avian derived* hyaluronic acid (HA) approved in the U.S. for treatment of knee pain due to osteoarthritis (OA). EUFLEXXA(R) is indicated for patients who have failed to get adequate pain relief either from simple pain medications, such as acetaminophen, or from exercise and/or physical therapy. The process used to manufacture EUFLEXXA(R) results in highly-purified HA with properties similar to the HA in healthy human synovial fluid.(2-4) EUFLEXXA(R) received approval from the U.S. Food and Drug Administration (FDA) on December 3, 2004, and became available to the public on November 8, 2005. For more information, visit www.EUFLEXXA.com.
EUFLEXXA(R) should not be used in people who have had any previous allergic reaction to hyaluronate preparations or who have knee joint infections or skin diseases in the area of the injection site. Common adverse events reported were arthralgia (joint pain) and back pain. Temporary knee pain and swelling may occur after injection. Strict aseptic technique must be followed to avoid joint infection.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of infertility, urology, and orthopaedic products in the U.S. market. They include: BRAVELLE(R) (urofollitropin for injection, purified), MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), Novarel(R) (chorionic gonadotropin for injection, USP), ENDOMETRIN(R) (progesterone) Vaginal Insert, 100 mg, PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, DEGARELIX for injection and EUFLEXXA(R) (1% sodium hyaluronate).
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For complete prescribing information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.
* Derived through bacterial fermentation
(1) Data on File, Ferring Pharmaceuticals
(2) Altman RD, Rosen JE. Six-month safety and efficacy of non-avian intra-articular hyaluronan in knee osteoarthritis (OA).
(3) Schiavinato A, Finesso M, Cortivo R, & Abatangelo G (2002). Comparison of the effects of intra-articular injections of Hyaluronan and its chemically cross-linked derivative (Hylan G-F20) in normal rabbit knee joints. Clin Exp Rheumatol 20, 445-454.
(4) Goomer RS, Leslie K, Maris T, & Amiel D (2005). Native hyaluronan produces less hypersensitivity than cross-linked hyaluronan. Clin Orthop Relat Res 239-245.
|SOURCE Ferring Pharmaceuticals Inc.|
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