SUFFERN, N.Y., April 10 /PRNewswire/ -- Ferring Pharmaceuticals Inc. announced recently that the U.S. Food and Drug Administration (FDA) has approved the Premarket Application (PMA) supplement for EUFLEXXA(TM) (highly purified hyaluronan) that allows the product to be stored at room temperature, as well as refrigerated. EUFLEXXA(TM) is a three-injection treatment given by physicians for the pain caused by knee osteoarthritis (OA). The new labeling was introduced to the medical community at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in Chicago, March 22-26, and product reflecting this label extension is now available to the public.
“EUFLEXXA(TM) has been extremely well received by physicians and patients alike since it was introduced in November 2005,” said Wayne Anderson, President, Ferring Pharmaceuticals Inc. “Patients are finding relief from the pain of knee osteoarthritis for the first time, after other first line treatments have failed. In fact, a head-to-head study showed that EUFLEXXA(TM) offers better symptom-free relief from knee OA pain than Synvisc(R), the market-leading HA therapy, with less use of simple analgesics and a lower incidence of joint effusion.(1) This new labeling makes it easier for physicians to store EUFLEXXA(TM) and keep it available for patients.”
In conjunction with this extension, the shelf life of EUFLEXXA(TM) will be 12 months. The newly labeled product will be designated by the same product code (sometimes referred to as NDC/HRI #) 55566-4100-1.
About EUFLEXXA(TM)
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 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. Since it is not derived from an avian source (chicken or rooster combs), the risk of related reactions is eliminated.(2),(3) In addition, EUFLEXXA(TM) has properties similar to the HA in healthy human synovial fluid and is 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 synovial fluid. Within a joint, HA is essential to water balance, viscosity, lubrication and the structure of cartilage.(8) In synovial fluid, 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 is a wide range of treatment options for 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 (ie. 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 include 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 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.
* Derived through bacterial fermentation EUFLEXXA is a trademark of Ferring Pharmaceuticals Inc. Synvisc is a registered trademark of Genzyme Corporation. (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 for FerringPharmaceuticals Inc., +1-203-762-8833, tfisher@KLCpr.com
