Flexion Therapeutics Presents Robust Phase 2b Data for FX006 at 2013 American College of Rheumatology Annual Scientific Meeting - In a clinical trial, a single-dose of 40 mg of FX006 demonstrated enhanced therapeutic effects relative to the approved injectable dose of commonly available, immediate release steroid in patients with osteoarthritis of the knee -

BURLINGTON, Mass., Oct. 30, 2013 /PRNewswire/ -- Flexion Therapeutics, Inc. announced today that new data from a Phase 2b dose-ranging clinical trial of the company's lead compound, FX006, were presented at the 2013 American College of Rheumatology Annual Scientific Meeting in San Diego, California. Flexion's Chief Medical Officer Neil Bodick, M.D., Ph.D., presented "A Randomized, Double-Blind, Dose Ranging Study Comparing FX006, an Intra-Articular (IA) Sustained-Release Formulation of Triamcinolone Acetonide (TCA), to an Approved Injectable Suspension of TCA in Patients with Osteoarthritis (OA) of the Knee." In his presentation, Dr. Bodick reported that patients with OA of the knee receiving a single injection of  FX006 in the 12 week clinical trial experienced enhanced pain relief relative to those patients receiving the currently available, approved injectable suspension of TCA (TCA suspension) over 12 weeks.

"We are delighted to be presenting these important data at the ACR Annual Meeting," said Michael Clayman, M.D., Flexion Therapeutics CEO. "We believe that the advantaged performance of FX006 demonstrates the potential of this new product to make a meaningful difference for the many patients who suffer the often debilitating effects of knee OA."  

The Phase 2b clinical trial of FX006, a novel intra-articular (IA), sustained release steroid, was a double-blind, comparator-controlled study in which 229 patients were randomized and treated with either 10 mg, 40 mg or 60 mg of FX006 or 40 mg of TCA suspension via intra-articular knee injection. The primary outcome measure was the weekly mean of the average daily pain intensity score (on the 0 – 10 Numeric Rating Scale) at weeks 1 through 12. Secondary endpoints included time to onset of analgesia, responder status, pain, stiffness and function measured using WOMAC, patient global impression of change and clinical global impression of change. FX006 at the 40 mg dose was significantly better than TCA suspension at improving pain relief based on the primary outcome measure beginning at week 5 and continuing to week 10 (p<0.05 at each time point). The FX006 40 mg dose also demonstrated significant improvement compared to TCA suspension in the average change from baseline in the primary outcome measure across weeks 1 to 12 (p=0.0382). Additionally, all key secondary endpoints at week 8 with the 40 mg dose of FX006 demonstrated significant improvement (p<0.05) compared to TCA suspension. In the trial, FX006 was well-tolerated with a safety profile that was comparable to that seen with the same dose of the TCA comparator.

"Given the consistently better and clinically meaningful pain relief observed in this clinical trial, we are enthusiastic about advancing the clinical development of FX006," said Dr. Bodick.

About FX006

FX006 is Flexion's novel, proprietary, sustained-release, intra-articular formulation of triamcinolone acetonide for the treatment of mild to moderate OA of the knee. It is designed to provide prolonged pain relief while avoiding untoward systemic effects associated with immediate release steroids. In a preclinical model of arthritis, FX006 demonstrated both superior efficacy to immediate release steroids and beneficial effects on structural progression. In a Phase 2 trial of pharmacokinetics and pharmacodynamics, FX006 maintained therapeutic concentrations in the knee joint significantly longer than TCA suspension and showed significantly reduced systemic exposures compared to the suspension formulation. FX006 has been well tolerated in all clinical trials thus far.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, long-acting, injectable pain therapies, beginning with osteoarthritis. Our pipeline consists of three proprietary product candidates: FX006, a sustained-release, intra-articular steroid; FX005, a sustained-release intra-articular p38 MAP kinase inhibitor; and FX007 a TrkA receptor antagonist for post-operative pain.

For more information, please visit http://www.flexiontherapeutics.com

SOURCE Flexion Therapeutics, Inc.



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