Navigation Links
Flexion's Lead Osteoarthritis Drug Candidate Demonstrates Significant, Prolonged Improvement in Pain and Function in Phase 2 Trial
Date:5/30/2012

WOBURN, Mass., May 30, 2012 /PRNewswire/ -- Flexion Therapeutics, Inc. today reported that its lead osteoarthritis drug candidate, FX005, demonstrated significant pain relief over placebo at four weeks* in a Phase 2 proof-of-concept trial. Top-line data showed FX005, delivered intra-articularly to the knee, was well-tolerated and resulted in prolonged improvement in joint pain and function throughout the 12-week duration of the study. These are the first-ever clinical results demonstrating the efficacy of a p38 MAP kinase inhibitor in osteoarthritis patients. Flexion plans to present the complete data set and analyses at an upcoming medical conference.

"There is considerable unmet need for treatments for the pain and damage caused by osteoarthritis," said Timothy McAlindon, chair of rheumatology and professor of medicine at Tufts Medical Center. "In particular, physicians and patients need targeted treatments for osteoarthritis that are more effective and longer lasting. These results represent a significant advance in that direction, so we will eagerly monitor development of this new treatment."

Michael Clayman, M.D., chief executive officer of Flexion, said, "We believe these data not only demonstrate the therapeutic potential of FX005 but also validate Flexion's approach to the treatment of osteoarthritis -- intra-articular delivery of sustained-release therapies providing prolonged activity at the site of disease while minimizing systemic exposure and the corresponding risk of systemic side effects. We are enthusiastic about advancing FX005 into the next phase of clinical development, which will be a Phase 2b dose-ranging study that we plan to initiate in the first half of 2013. The data from that study will then be used to identify an optimal dose for Phase 3."

The trial was a double-blind, placebo-controlled study in which 104 patients were randomized to receive FX005 or placebo via intra-articular injection. Each patient was evaluated using the WOMAC® Osteoarthritis Index to assess pain and function at two, four, eight and 12 weeks.

*as measured by WOMAC A (Western Ontario and McMaster Universities Osteoarthritis Index)

About OsteoarthritisOsteoarthritis is a leading cause of disability that affects more than 27 million adults in the U.S. and more than 100 million people worldwide. Almost 50% of people in the U.S. will experience the pain of osteoarthritis in their lifetime. Current treatment is inadequate. Oral therapies have limited pain relief and serious cardiovascular, liver and gastrointestinal side effects as well as black box warnings. Available intra-articular therapies are generally well-tolerated but provide limited therapeutic efficacy or provide good pain relief with an inadequate duration of effect. Despite these inadequacies, there are over 50 million intra-articular injections per year worldwide with sales in excess of $1.5 billion a year.

About FX005FX005 is Flexion's novel, sustained release, intra-articular inhibitor of p38 MAP kinase, a clinically validated target in pain and inflammation, and is positioned as second-line therapy following intra-articular steroids for the treatment of moderate osteoarthritis of the knee. FX005 is an anti-inflammatory drug-candidate that incorporates analgesic effects and has the potential to modify disease progression.

About Flexion TherapeuticsFlexion discovers and develops innovative therapeutics for musculoskeletal disorders. In our efforts to provide products with superior efficacy and safety, we are merging novel pharmacology with local, sustained delivery of drug to the site of disease -- an approach that aims to ensure lasting therapeutic effect and systemic safety. We are currently advancing a portfolio of best-in-class drug candidates that have the potential to treat mild, moderate and severe forms of this debilitating disorder.

For more information please visit www.flexiontherapeutics.com.Media ContactsCorporate ContactTony Russo, Ph.D.Lisa Davidson, MBAMatt Middleman, M.D.Vice President, Finance and AdministrationRusso PartnersT: 781-897-9965T: 212-845-425ldavidson@flexiontherapeutics.comT: 212-845-4272 tony.russo@russopartnersllc.commatt.middleman@russopartnersllc.com  


'/>"/>

SOURCE Flexion Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Evidence of Benefit Lacking for Many Common Ways of Treating Osteoarthritis of the Knee
2. Cost-Effectiveness Study Supports Use of EUFLEXXA(TM) by Rheumatologists for Pain Relief in Patients with Knee Osteoarthritis
3. Acologix Presents Preclinical Data on Cartilage Regeneration by AC-100 at the OARSI 2007 World Congress on Osteoarthritis
4. Osteoarthritis: Which Treatments Work and Which Dont?
5. Patients Taking Cymbalta(R) Reported Reduced Pain Severity of Osteoarthritis of the Knee in New Study
6. Study Shows Pine Bark Naturally Reduces Knee Osteoarthritis
7. Interleukin Genetics to Present Important New Findings at 2008 World Congress on Osteoarthritis
8. Study Shows EUFLEXXA(R) Patients Report Significant Improvements in Osteoarthritis of the Knee Pain over a Six Month Period
9. ESBATechs Antibody Fragment Enters Phase I/IIa Clinical Development in Osteoarthritis with the Potential for Disease-Modifying Activity
10. Cymbalta(R) Significantly Reduced Osteoarthritis Knee Pain in New Study
11. New Treatment Against Osteoarthritis: Orthokine Therapy Highly Effective Against Knee Arthritis After Two Years
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... -- A Mederi Therapeutics Inc . anunciou aprovação regulatória, pela CFDA, e lançamento ... do refluxo gastroesofágico (DRGE). Foto -  http://photos.prnewswire.com/prnh/20161207/446903 ... ... Stretta procedure performed and broadcast during the Chinese Congress of Digestive Endoscopy, by ... , , ...
(Date:12/8/2016)... 2016  A new study by a pair of ... opioid therapy to treat chronic pain is not only ... harmful consequences, including death. Palliative care physicians ... Mehta , M.D., authored the study which provides a ... The study was published in the December 2016 edition ...
(Date:12/8/2016)... , Dec. 8, 2016 A Small Business ... National Institutes of Health (NIH) to Phoenix ... The grant will seek to determine ... device, which utilizes electromagnetic waves to treat Alzheimer,s Disease. ... novel technology to possibly treat other neurologic disorders such ...
Breaking Medicine Technology:
(Date:12/8/2016)... Fla (PRWEB) , ... December 08, 2016 , ... ... smarter modes of access for customers and employees that are both engaging and ... 7 with Service Smart Technology, the software company revealed today its plans to ...
(Date:12/8/2016)... ... December 08, 2016 , ... California Senate Bill (SB) 863, signed into law ... in 2013 and 2014, according to CompScope™ Medical Benchmarks for California, 17th Edition ... to the study, medical payments per claim in California decreased 4 percent in 2013 ...
(Date:12/8/2016)... ... 08, 2016 , ... The Dianne Michael Insurance Agency, an ... County, is embarking on a charity drive with the aim of generating support ... orphaned or neglected senior dogs in the Cincinnati region, and LuvFurMutts volunteers also ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... consulting services to residential and commercial clients in the northern Alabama and Georgia ... Nobis Works. , Since 1977, Nobis Works has built a network of support ...
(Date:12/7/2016)... ... ... Kenall Manufacturing, a leader in sealed healthcare lighting for more than 30 ... sealed, LED luminaire that meets the needs of everyone in the patient room by ... , A 2’ x 4’ model features four modes: reading, ambient, standard and high ...
Breaking Medicine News(10 mins):