Data from Flexion Therapeutics' FX006 Phase 2b trial for OA to be presented at ACR/ARHP meeing

Flexion Therapeutics, Inc.Oct 2 2013

Flexion Therapeutics, Inc. announced today that new data from a Phase 2b dose-ranging trial of the company's lead compound, FX006, in osteoarthritis (OA) has been accepted for an oral presentation at the 2013 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP). Flexion's Chief Medical Officer Neil Bodick, M.D., Ph.D., will present the data during the meeting on October 29, 2013, in San Diego, California.

Information for the oral presentation session is highlighted below:

(Abstract #2668): Tuesday, October 29, 2013, 2:30 PM PST "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," [Osteoarthritis I: Therapeutics in Osteoarthritis] [Hilton 306-A]

"We are excited to present these Phase 2b data since they show magnitude of pain relief with FX006 that is among the largest observed in clinical trials," said Michael Clayman, M.D., Flexion Therapeutics CEO. "FX006 was also well tolerated and overall the data indicate that FX006 has the potential to provide a more effective treatment option than current immediate release steroids."

The Phase 2b trial of FX006, a novel intra-articular (IA), sustained release steroid, was a double-blind, comparator-controlled study in which 228 patients were randomized to receive 10 mg, 40 mg or 60 mg of FX006 or 40 mg TCA IR 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 measured time to onset of analgesia, responder status, pain, stiffness and function measured using WOMAC, patient global impression of change, clinical global impression of change and rescue medical consumption. In the trial, FX006 demonstrated clinically meaningful, statistically significant and prolonged pain relief relative to the commonly prescribed, immediate release steroid, triamcinolone acetonide (TCA IR).