Flexion Posts Good OA Results

Flexion Therapeutics has presented new data from a Phase IIb dose-ranging trial of its lead compound, FX006, at the 2013 American College of Rheumatology Annual Scientific Meeting in San Diego, CA.

The company reported that patients with osteoarthritis (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.

The 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 one 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 five and continuing to week 10.