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.
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 three-injection treatment regimen for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (eg, acetaminophen). In a prospective, randomized, double-blind head-to-head study versus the market-leading HA therapy, significantly more patients were "pain-free" and "symptom-free" with EUFLEXXA.(1)
The process used to manufacture EUFLEXXA produces the HA that most closely resembles the HA in healthy human synovial fluid and the most highly purified HA product available today. In addition, since it is not derived from an avian source (chicken or rooster combs), the risk of reactions related to avian proteins is eliminated.(2-7)
EUFLEXXA received PMA 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 http://www.EUFLEXXA.com.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc., part of the Ferring Group, is a privately owned, international pharmaceutical company. Ferring's line of products includes: EUFLEXXA (hyaluronic acid) for pain from osteoarthritis in the knee; BRAVELLE(R) (urofollitropin for injection, purified); MENOPUR(R) (menotropins for injection, USP); REPRONEX(R) (menotropins for injection, USP); NOVAREL(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN(R) (progesterone) Vaginal Insert for infertility. Ferring offers the Q?CAP(TM), the first needle-free reconstitution device, for use with its fertility treatments.
Other products include: ACTHREL(R) (corticorelin ovine triflutate for injection) for the differential diagnosis of Cushing's syndrome; DESMOPRESSIN ACETATE in injectable and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis; and PROSED(R) DS for the relief of discomfort of the lower urinary tract.
The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology, orthopaedics and infertility. For more information, call 888-337-7464 or visit http://www.FerringUSA.com.
INDICATION AND Important Treatment Considerations
EUFLEXXA(R) (1% sodium hyaluronate) is indicated for the treatment of knee pain due to osteoarthritis (OA). It is used in people who have failed to get adequate pain relief either from simple pain medications, such as acetaminophen, or from exercise and/or physical therapy. 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. In a randomized, double-blind, multicenter clinical trial, the only adverse events reported with EUFLEXXA(R) at an incidence of 5% or greater were arthralgia (joint pain) (8.75%) and back pain (5%). Temporary knee pain and swelling may occur after injection with EUFLEXXA(R). The safety and effectiveness of injecting EUFLEXXA(R) into the knee together with other injectable medications or into joints other than the knee have not been studied. The safety and effectiveness of treatment cycles of fewer than 3 injections or of repeated treatment cycles with EUFLEXXA(R) have not been established. Strict aseptic technique must be followed to avoid joint infection.
It is recommended to avoid strenuous activity or prolonged weight-bearing activities such as jogging or tennis within 48 hours following intra-articular injection.
(1) Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006; 14:154-162.
(2) 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.
(3) Goomer RS, Leslie K, Maris T, & Amiel D (2005). Native hyaluronan produces less hypersensitivity than cross-linked hyaluronan. Clin Orthop Relat Res 239-245.
(4) Leopold SS, Warme WJ, Pettis PD, & Shott S (2002). Increased frequency of acute local reaction to intra-articular hylan GF-20 (synvisc) in patients receiving more than one course of treatment. J Bone Joint Surg Am 84-A, 1619-1623.
(5) Puttick MP, Wade JP, Chalmers A, Connell DG, & Rangno KK (1995). Acute local reactions after intraarticular hylan for osteoarthritis of the knee. J Rheumatol 22, 1311-1314.
(6) Pullman-Mooar S, Mooar P, Sieck M, Clayburne G, & Schumacher HR (2002). Are there distinctive inflammatory flares after hylan g-f 20 intraarticular injections? J Rheumatol 29, 2611-2614.
(7) Chen AL, Desai P, Adler EM, & Di Cesare PE (2002). Granulomatous inflammation after Hylan G-F 20 viscosupplementation of the knee: a report of six cases. J Bone Joint Surg Am 84-A, 1142-1147.
|SOURCE Ferring Pharmaceuticals Inc.|
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