Navigation Links
Flexion's Lead Osteoarthritis Drug Candidate Demonstrates Significant, Prolonged Improvement in Pain and Function in Phase 2 Trial

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 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  


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:
(Date:11/29/2015)... Nov. 29, 2015   Royal Philips  (NYSE: PHG, ... solutions at the 2015 Radiological Society of North America ... McCormick Place in Chicago . Visitors ... the company,s broad portfolio of integrated Diagnostic Imaging, Clinical ... increase clinical performance, improve workflow and create a superior ...
(Date:11/29/2015)...  The GE Health Cloud 1 was unveiled today ... North America (RSNA) meeting in ... new cloud ecosystem and its applications will connect radiologists and ... multidisciplinary teams – both inside and outside the hospital setting. ... GE. "As the digital industrial leader, we are betting big ...
(Date:11/29/2015)... , Nov. 29, 2015   National Decision ... of its client base, including notable statewide implementations. ... company,s flagship solution, ACR Select, more than 1 ... order entry workflow. ACR Select provides real-time feedback ... patient,s condition and has been implemented at over ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... ... the toilets were," said an inventor from Hillside, N.J. "Many people catch diseases ... cover so that individuals will always be protected from germs." , He developed ...
(Date:11/27/2015)... ... 27, 2015 , ... MPWH, the No.1 Herpes-only dating community in the world, revealed that over ... More than 3.7 billion people under the age of 50 – or 67% of ... WHO's first global estimates of HSV-1 infection . , "The data shocks us highly!" ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... prided itself for not only fulfilling the needs of advisers and clients but ... affordable price and providing top-tier customer service. However, there's always room for improvement, ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... ... California Medical Associates, Inc. and Dr. Tucker Bierbaum with Emergency Medicine at ... They observed that both STEMI and Sepsis conditions present in similar ways and require ...
(Date:11/26/2015)... NV (PRWEB) , ... November 26, 2015 , ... Inevitably ... strategy. Many customers choose to buy during the Black Friday and Cyber Monday ... Shoppers don’t need to search the Internet high and low to find the best ...
Breaking Medicine News(10 mins):