Navigation Links
Ferring Pharmaceuticals Unveils Six-Month Efficacy Data for EUFLEXXA(R) for the Treatment of Osteoarthritis Knee Pain
Date:5/13/2009

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.

About EUFLEXXA(R)

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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. deCODE and Radboud University Discover Common Variants in the Human Genome Conferring Risk of Bladder Cancer
2. Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
9. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
10. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
11. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... 52" report to their offering. ... creates a favourable commercial environment for MedImmune to enter. The ... that will serve to drive considerable growth for effective anti-influenza ... to cap sales considerably, but development is still in its ...
(Date:6/23/2016)... Ill. and INDIANAPOLIS , ... students receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is ... 2016 scholarship winners, announced today online at www.diabetesscholars.org ... let type 1 diabetes stand in the way of ... has supported the Foundation,s scholarship program since 2012, and ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... ... 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping to ... app. The fitness app plans to fix the two major problems leading the fitness industry ... fits all type program , They don’t eliminate all the reasons people quit ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can ... Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey ... cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under ...
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health ... of their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards ... at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to ...
Breaking Medicine News(10 mins):