Navigation Links
Study Shows EUFLEXXA(R) Patients Report Significant Improvements in Osteoarthritis of the Knee Pain over a Six Month Period
Date:10/7/2008

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.

About EUFLEXXA

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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD
2. Ironwood and Forest Present Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
3. New Findings Show Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohns Disease According to First-of-its Kind Study
4. Genaera Corporation Reports Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting
5. Complete Genomics and the Institute for Systems Biology Announce Partnership to Conduct the First Human Genome Population Study
6. The Childrens Hospital of Philadelphia Announces New Regional Participant in The National Childrens Study
7. Xalieve(TM) Gains Momentum as Calabar AB Launches a Phase II Repeated Dose Study in Dry Mouth Patients
8. Circassia Initiates Further Phase II Clinical Study of Toleromune(R) Anti-Allergy Technology
9. Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study
10. Evalve Announces Enrollment Completion of the EVEREST Randomized Study
11. Swedish in Seattle to Study Connections Between Preeclampsia and Migraine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/7/2017)... , Aug. 7, 2017 Zimmer Biomet Holdings, Inc. ... today announced that its Board of Directors has approved the ... third quarter of 2017. ... on or about October 27, 2017 to stockholders of record ... Future declarations of dividends are subject to approval of the ...
(Date:8/7/2017)... 2017  Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation,s largest ... June 30, 2017.  All comparisons, unless otherwise noted, are to ... Second Quarter 2017 Highlights include: ... an increase of 3.5% Total prescriptions dispensed ... of 7.5% versus 7.6% Gross profit ...
(Date:8/4/2017)... 2017 The search for test results that ... consult has long been the goal of healthcare providers ... of the largest meeting of lab professionals and IVD ... research firm Kalorama Information.  The firm said scores of ... related supplies and software were at the American Association ...
Breaking Medicine Technology:
(Date:8/16/2017)... NJ (PRWEB) , ... August 16, 2017 , ... With low back pain afflicting 8 ... know what causes its kissing cousin – upper back pain. But this equally vexing condition ... treatment options, according to Kaixuan Liu, MD, PhD , founder and president of Atlantic ...
(Date:8/16/2017)... ... August 16, 2017 , ... “Mom, God's Got This: Jamie's Story” is the creation ... with the Lord and has an insatiable appetite for God’s Word. , “I froze between ... free gifts retrieved from packages of oatmeal. I have one to this day on proud ...
(Date:8/15/2017)... Buffalo, NY (PRWEB) , ... August 15, 2017 , ... ... as maintenance treatment for multiple myeloma has been completed, with the team’s findings now ... Philip L. McCarthy, MD , Director of the Blood and Marrow Transplant Program at ...
(Date:8/15/2017)... ... 15, 2017 , ... Horizon Goodwill is honored to receive ... overwhelmed with gratitude for the very generous donation from BB&T. Our mission is ... get a job and keep it. This donation will go a long way ...
(Date:8/15/2017)... ... August 15, 2017 , ... ... to announce the 19th Annual V Foundation Wine Celebration raised nearly $9 million ... more than $7 million in “Fund-A-Need” donations to support the study of BRCA ...
Breaking Medicine News(10 mins):