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:2/23/2017)... , February 23, 2017 ... report on the global market for intraoperative imaging, ... presently valued at US$ 513.9 million. According to ... keep surging on the grounds of increasing adoption ... the field of diagnostic imaging for neurosurgeries. The ...
(Date:2/23/2017)... The top three players dominating ... Koninklijke Philips N.V., and Schiller. Collectively, these companies held ... in 2015. Strong product portfolio and a monumental geographical ... aiding these players remain leaders in the fragmented competitive ... the global market are likely to focus on mergers ...
(Date:2/23/2017)... On Wednesday, February 22, 2017, US markets saw ... sectors finished the trading sessions in green, four closed in ... indices were also mixed at the close of yesterday,s session. ... by 0.09%; the Dow Jones Industrial Average edged 0.16% higher, ... 2,362.82, down 0.11%. This Thursday morning, Stock-Callers.com looks at the ...
Breaking Medicine Technology:
(Date:2/22/2017)... ... 22, 2017 , ... The Waismann Method® is providing a faster, ... recently fallen victim to America’s opioid epidemic. Now, opiate dependent individuals can be treated ... free from the shame, stigma, and harmful labeling believed to prevent many ...
(Date:2/22/2017)... ... February 22, 2017 , ... The National Academy of Certified ... the April 2017 testing period. NACCM, a nonprofit organization, has provided the premier ... exam is periodically re-calibrated to ensure that newly certified professionals are prepared to ...
(Date:2/22/2017)... ... February 22, 2017 , ... Giving ... fewer trips the emergency room, fewer hospital admissions, and better blood pressure and ... Care® (AJMC®) finds. The study can be found here . , The ...
(Date:2/22/2017)... ... 2017 , ... In a 2012 survey, over a quarter ... a prescription because they could not afford to pay for it. Among those ... At the same time, hospitals, pharmacies, manufacturers and nursing homes dispose ...
(Date:2/22/2017)... Los Angeles, CA (PRWEB) , ... February 22, 2017 , ... ... with the recent addition of esteemed ophthalmologist, Dr. Steven H. Rauchman, practicing at ... are common in auto accidents, product liability, premise liability and other personal injury cases. ...
Breaking Medicine News(10 mins):