Navigation Links
FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
Date:10/21/2011

PARSIPPANY, N.J., Oct. 21, 2011 /PRNewswire/ -- On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles.

The FLEXX trial was a 26-week multicenter, randomized, double-blind study evaluating the safety and efficacy of EUFLEXXA, compared with saline, in patients with painful osteoarthritis of the knee. Patients received three weekly injections of either EUFLEXXA or saline into the target knee. Following the double-blind portion of the trial, patients were offered to receive an additional three weekly injections of EUFLEXXA in a 26-week open-label safety extension. Results from the double-blind portion of the study showed patients treated with EUFLEXXA had a statistically and clinically significant decrease in osteoarthritis knee pain compared to those who received saline control injections as measured by a 50-foot walk test at week 26.

The number of patients reporting adverse events was generally similar between the EUFLEXXA and saline groups. The most common adverse events (>2%) reported in patients treated with EUFLEXXA were: arthralgia, hypertension, back pain, upper respiratory tract infection, diarrhea, injury and cough. In addition, results of the open-label extension demonstrated that repeated injection cycles of EUFLEXXA were well-tolerated up to 52 weeks. In this open-label portion of the study, the most commonly reported adverse events (>2%) were: arthralgia, nasopharyngitis, injury, back pain, joint swelling, upper respiratory tract infection and sinusitis.

"The results further support EUFLEXXA as the first bioengineered, non-avian, effective treatment option that provides osteoarthritis knee pain relief lasting up to six months. The labeling also reflects safety with repeated injection cycles," said Dr. Paul Korner, Senior Vice President,
'/>"/>

SOURCE Ferring Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/3/2015)... This Defibrillators are critical life saving devices ... across globe. This report provides in-depth analysis of defibrillators ... . Stakeholders for this report include manufacturers of ... bodies. The Saudi Arabia defibrillators ... and by end users. In terms of products the ...
(Date:9/3/2015)... 2015 Nevro Corp. (NYSE: NVRO ), ... evidence-based solutions for the treatment of chronic pain, today ... Morgan Stanley Global Healthcare Conference on Thursday, September 17, ... management is scheduled to present at 11:45 a.m. ET. ... webcast, accessible in the "Investors" section of the company,s ...
(Date:9/3/2015)... , Sept. 3, 2015  Ascendis ... clinical stage biotechnology company that applies its ... medical needs, today announced plans to present ... Wells Fargo Healthcare Conference in BostonDate: , ... , Bank of America Merrill Lynch Global ...
Breaking Medicine Technology:Saudi Arabia Defibrillators Market: & Advanced Life Support Defibrillators; End Users; Industry Analysis, Size, Volume, Growth, Trends and Forecast 2014 - 2020 2Ascendis Pharma A/S to Present at Three Upcoming Investor Conferences 2
... publishing group,s leading brands European Medical Device Technology ... Industry ( MD+DI ) and Qmed® ... on May 24, 2011.  Devoted to developments in materials for ... opportunity to learn from and interact directly with industry experts, ...
... Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic implants, ... Geelong, Australia by Richard S. Page, MB.BS.FRACS(ORTH) at St. John ... 57-year-old, active male with increasing shoulder pain for over a ... bike and not improved by a full range of non-surgical ...
Cached Medicine Technology:UBM Canon's Virtual Event Dedicated to Developments in Materials for Medical Applications 2UBM Canon's Virtual Event Dedicated to Developments in Materials for Medical Applications 3Ascension Orthopedics Implants PyroTITAN™ in Geelong, Australia 2
(Date:9/4/2015)... ... September 04, 2015 , ... The conference program ... Hollywood, Florida October 9-10, 2015 at the Diplomat Resort & Spa has been ... doctors and researchers at the top of their field and will be presenting ...
(Date:9/4/2015)... ... September 04, 2015 , ... Steven Winter Associates, Inc., ... has been selected for the Residential Award of Merit by the Connecticut Green ... Chosen from a highly competitive field of submissions, the net-zero energy residence will ...
(Date:9/4/2015)... ... 2015 , ... EMED Jamaica Global Ltd. (EMED), Jamaica’s premier ... into a multi-year agreement with Health City Cayman Islands. , ( http://www.healthcitycaymanislands.com ) ... healthcare, Jamaican healthcare and Health City Cayman Islands to deliver high-quality, affordable healthcare ...
(Date:9/3/2015)... Calif. (PRWEB) , ... September 03, 2015 , ... Allied ... Fullerton, where innovative medicine is the norm not the exception. , St. Jude was ... the American Heart Association/American Stroke Association, making it one of only 10 hospitals in ...
(Date:9/3/2015)... ... September 03, 2015 , ... The Oregon Collaborative ... of Integrative Health & Medicine (AIHM) Interprofessional Fellowship in Integrative Health & Medicine. ... MD, an internationally renowned educator, physician and thought leader in integrative medicine. This ...
Breaking Medicine News(10 mins):Health News:Integrative Healthcare Symposium Focus On: The Microbiome Conference Program Announced 2Health News:South Glastonbury Home Selected for Award by Connecticut Green Building Council 2Health News:EMED Agreement with Health City Cayman Islands Provides for Up to 80% Savings for Patients in Need of Medical Procedures 2Health News:EMED Agreement with Health City Cayman Islands Provides for Up to 80% Savings for Patients in Need of Medical Procedures 3Health News:EMED Agreement with Health City Cayman Islands Provides for Up to 80% Savings for Patients in Need of Medical Procedures 4Health News:EMED Agreement with Health City Cayman Islands Provides for Up to 80% Savings for Patients in Need of Medical Procedures 5Health News:EMED Agreement with Health City Cayman Islands Provides for Up to 80% Savings for Patients in Need of Medical Procedures 6Health News:Allied Anesthesia Physicians Announce Partnership with St. Jude 2Health News:Allied Anesthesia Physicians Announce Partnership with St. Jude 3Health News:Oregon Collaborative for Integrative Medicine Partners with AIHM on First Interprofessional Fellowship 2Health News:Oregon Collaborative for Integrative Medicine Partners with AIHM on First Interprofessional Fellowship 3
... larger tumors , , THURSDAY, March 19 (HealthDay News) -- ... tumor improves tumor-free survival, a U.S. study has confirmed. ... cancer of the intestinal tract, typically occur in the ... are diagnosed in the United States each year. According ...
... Pharmaceuticals (NYSE: VRX ) today announced that ... of President, Valeant Pharmaceuticals International, effective March 10, 2009. ... for overseeing the Dow Services business, corporate business development ... and will be a member of Valeant,s Executive Management ...
... Abaxis, Inc. (Nasdaq: ABAX ), a ... today that Don Wood, vice president of operations, will ... on Thursday, March 26, 2009. The conference is a ... be held at the Cliff Lodge Snowbird Ski Resort ...
... Based on its recent analysis of the medical ... with the 2009 North American Frost & Sullivan ... The honor serves as recognition of the growth ... upon since the firm,s acquisition of Dynamic Imaging ...
... Anesthesiologists, Action vs. RhetoricCORONA DEL MAR, Calif., March 19 ... fair odds. Yet, that,s exactly what the foremost international ... the stage for last week when he responded to ... release in which they claimed to be in the ...
... ... OH (PRWEB) March 19, 2009 -- Female patients who require the removal ... extracted completely through the vagina, thanks to a new surgical procedure developed ... , , ,Dr. Jihad Kaouk, Director of the Center for Laparoscopic and ...
Cached Medicine News:Health News:Gleevec Prevents Return of Intestinal Cancer, Study Confirms 2Health News:Valeant Pharmaceuticals Appoints President of Valeant Pharmaceuticals International 2Health News:Valeant Pharmaceuticals Appoints President of Valeant Pharmaceuticals International 3Health News:Frost & Sullivan Recognizes GE Healthcare for Strategic Leadership in Acquiring Dynamic Imaging to Grow Its Imaging Informatics Business 2Health News:Frost & Sullivan Recognizes GE Healthcare for Strategic Leadership in Acquiring Dynamic Imaging to Grow Its Imaging Informatics Business 3Health News:Frost & Sullivan Recognizes GE Healthcare for Strategic Leadership in Acquiring Dynamic Imaging to Grow Its Imaging Informatics Business 4Health News:Frost & Sullivan Recognizes GE Healthcare for Strategic Leadership in Acquiring Dynamic Imaging to Grow Its Imaging Informatics Business 5Health News:Dr. Barry Friedberg comments on David vs. Goliath: Who's Really in the Pursuit of Patient Safety & Satisfaction? 2Health News:Cleveland Clinic First To Perform Nephrectomy Completely Transvaginally 2Health News:Cleveland Clinic First To Perform Nephrectomy Completely Transvaginally 3
Complete Blink-N-Clean lens drops cleans and clears lenses in a blink. It is a unique blend of gentle to the eye ingredients that conveniently cleans, clears and keeps lenses feeling comfortable thro...
Renu rewetting drops soothe your eyes and moisturize soft contact lenses to minimize dryness....
Softwear Saline with unique comfort rinsing formula....
Sensitive Eyes sterile saline spray is the preservative-free aerosol saline solution for people with eyes sensitive to preservatives. Used for rinsing soft contact lenses after cleaning or thermal or...
Medicine Products: