February 13, 2006
Head-to-Head Study Shows EUFLEXXA(TM) Has Greater Tolerability Compared to Synvisc(R) for Osteoarthritis Knee Pain
SUFFERN, N.Y., Feb. 13 /PRNewswire/ -- An important head-to-head study has demonstrated the efficacy and greater tolerability of EUFLEXXA(TM) (highly purified hyaluronan) compared to Synvisc(R)*, an avian-derived hyaluronan and the leading hyaluronic acid (HA) product in its class for the treatment of osteoarthritis (OA) knee pain.(1) In the 12-week trial of 321 patients, EUFLEXXA(TM) showed statistically significant advantages over Synvisc: more patients treated with EUFLEXXA(TM) were symptom-free (p=0.038), there was a lower incidence of joint effusion (p=0.0015), fewer patients required supplemental simple analgesics (p=0.013), and more patients reported being "very satisfied" (p=0.03). The study was published in the February 2006 issue of Osteoarthritis and Cartilage.
EUFLEXXA(TM) is the first and only hyaluronic acid (HA) approved in the U.S. for the treatment of the pain of knee osteoarthritis that is not derived from an avian source** (chicken or rooster combs). This eliminates the risk of related reactions.(2),(3) EUFLEXXA(TM) 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 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.
"This study shows that EUFLEXXA(TM) offers better symptom-free relief from OA pain over a 12-week period than the market-leading HA therapy with less use of simple analgesics," said Wayne Anderson, President, Ferring Pharmaceuticals Inc. "For the growing number of Americans who live with the pain caused by knee osteoarthritis, this study demonstrates the greater tolerability of EUFLEXXA(TM) compared to the leading therapy in its class."
About the Study
In a prospective, multicenter, randomized, double-blind controlled trial, 321 patients with confirmed knee osteoarthritis were randomized to treatment with either EUFLEXXA(TM) (n=160) or Synvisc (n=161). The Western Ontario McMaster Universities Osteoarthritis (WOMAC) Index pain subscale was the primary efficacy measure. Both products were administered as a course of three weekly injections, with follow-up evaluations at weeks 3, 6 and 12. Both treatment groups experienced statistically significant improvements from baseline (p=0.0001). EUFLEXXA(TM) (WOMAC pain score = 29.8 mm (-61.6%)) was shown to be comparable in efficacy to Synvisc (WOMAC pain score = 28.8 mm (-54.9%)).(1) At the study endpoint, 63% of patients treated with EUFLEXXA(TM) were symptom-free compared with 52% of those treated with Synvisc (p=0.038), as determined by a VAS (100-mm visual analog scale) score of
EUFLEXXA(TM) also showed a significant advantage over Synvisc in the number of joint effusions (p=0.0015), patients requiring supplemental simple analgesics (p=0.013), and patient satisfaction (p=0.03). For patient satisfaction, 50% of EUFLEXXA(TM) patients were 'very satisfied' with treatment results compared to 37% for the Synvisc group. A subanalysis performed on patients with unilateral OA found that only 49% of patients treated with EUFLEXXA(TM) used supplemental simple analgesics compared to 82% of those treated with Synvisc (p=0.001).(1)
EUFLEXXA(TM) (1% sodium hyaluronate) is the first and only non-avian- derived hyaluronic acid approved in the U.S. for the treatment of pain caused by knee osteoarthritis. The process used to manufacture EUFLEXXA(TM) results in ultra-high-purity HA with properties similar to the HA in healthy human synovial fluid. EUFLEXXA(TM) is also free of chemical cross-linking, which minimizes the risk of related reactions.(2-7)
EUFLEXXA(TM) 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 http://www.euflexxa.com/.
About Hyaluronic Acid
HA is a viscous, elastic liquid that is naturally found in many tissues of the body and in high concentrations in joint cartilage and synovial fluid. Within a joint, HA is essential to water balance, viscosity, lubrication and the structure of cartilage.(8) In cartilage, HA binds to other molecules, helping it withstand weight-bearing force and movement of the joint. Inside the knee joint, HA provides a cushion to protect the joint from mechanical damage and acts as both a shock-absorbing fluid and regulator of water and metabolites.
Osteoarthritis and the General Population
The Arthritis Foundation estimates that 66 million Americans are affected by arthritis, half of whom are unaware of available treatments, and that the disease costs the U.S. economy more than $86.2 billion annually. The Foundation also estimates that 21 million American adults suffer from osteoarthritis.(9) Osteoarthritis, a form of arthritis, affects certain parts of the body, most commonly the knee. Over time, articular cartilage in the knee loses elasticity and becomes worn. As a result, the bony surfaces of the joint can grind together and eventually wear the cartilage away entirely. This leads to symptoms of pain, stiffness and impaired joint movement. There are a wide range of treatment options for the pain of knee OA, including behavior modification, drug therapy, injections within the joint and knee replacement surgery.
Non-steroidal anti-inflammatory drugs (NSAIDs) are common first-line pharmacologic treatments for knee pain relief. Serious side effects and risks (i.e. potentially life-threatening stomach bleeding and kidney disease) have been associated with such treatments. The effectiveness of different treatments varies from person-to-person and with the severity of the condition. Treatment options are generally a shared decision between the patient and his/her physician with total knee replacement surgery usually sought as the last option.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc., part of the Ferring Group, is a privately owned, international pharmaceutical company. Ferring's line of orthopaedic and urology products includes EUFLEXXA(TM), hyaluronic acid for the treatment of pain from osteoarthritis of the knee and degarelix for prostate cancer (Phase III).
Ferring also markets Menopur(R) (menotropins for injection, USP), Bravelle(R) (urofollitropin for injection, purified), Repronex(R) (menotropins for injection, USP) and Novarel(R) (chorionic gonadotropin for injection, USP) in the U.S. to infertility specialists and their patients. Ferring offers the Q-CAP(TM), the first and only 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 and generic desmopressin acetate in injectable and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis.
The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information, visit http://www.ferringusa.com/.
* Synvisc is a registered trademark of Genzyme Corporation. ** Derived through bacterial fermentation (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. (8) Abatangelo, G., O'Regan. Hyaluronan: Biological Role and Function in Articular Joints. European Journal of Rheumatology and Inflammation; Vol15(1) 1995. (9) Arthritis Rheum 1999; 41(5):778-799
Ferring Pharmaceuticals Inc.
CONTACT: Tara Fisher of Kovak-Likly Communications, +1-203-762-8833,[email protected], for Ferring Pharmaceuticals Inc.
Web site: http://www.ferringusa.com/http://www.euflexxa.com/