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:2/12/2016)... 12, 2016 /PRNewswire/ - Demers Ambulances announces its first delivery in ... Okaloosa County Emergency Medical Services (EMS) consisting ... one LT2 van. Quality Emergency Vehicles in Lecanto, ... the sale.  This is the latest in Demers, ongoing expansion ... President at Demers. --> Benoit LaFortune , Executive ...
(Date:2/12/2016)... , Feb. 12, 2016   HeartWare International, ... conference call and webcast to discuss its financial results ... 2015, on Thursday, February 25, 2016 at 8:00 a.m. ... prior to the conference call and webcast.  On the ... financial results, highlights from the fourth quarter and business ...
(Date:2/12/2016)... ALISO VIEJO , Kalifornien, 12. Februar 2016 ... es mit der Aufnahme von Patienten für eine ... Embolisation von Aneurysmen („WEB") speziell für die Behandlung ... Laurent Spelle , MD, Leiter der Neuroradiologie an ... , Frankreich, und Hauptprüfarzt der CLARYS-Studie hat den ...
Breaking Medicine Technology:
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... CDRH Enforcement Trends: , Back to the ... , As Winston Churchill said, “Those who don’t learn from history are ... what to expect when they come knocking this year. But that takes time. , ...
(Date:2/12/2016)... ... February 12, 2016 , ... Each year, the American Physical ... in Anaheim, CA at the Anaheim Convention Center. Almost 10,000 physical therapists across the ... products in action, learn more about their chosen field and network with their colleagues. ...
(Date:2/12/2016)... CULVER CITY, California (PRWEB) , ... February 12, 2016 , ... ... to announce their participation in Red Carpet Events LA GRAMMY’s Style Lounge Event. Coco ... and healthy way to stay hydrated before the big event. The invitation-only gifting suite, ...
(Date:2/12/2016)... ... February 12, 2016 , ... The ThedaCare ... San Francisco General Hospital on April 5-7. The series is a multi-day, multi-workshop ... habits. The workshops cover a broad range of topics, including coaching skills, the ...
(Date:2/12/2016)... ... 12, 2016 , ... Every winter, someone is killed, injured or loses a ... Burn Center, part of the Allegheny Health Network, has partnered with Etna Volunteer ... Heaters Need Space” campaign. , “Space Heaters Need Space” aims to bring ...
Breaking Medicine News(10 mins):