FX006 demonstrates pain relief in Phase 2b osteoarthritis study, Flexion reports

Flexion Therapeutics, Inc., today reported that its lead compound FX006, a novel intra-articular (IA), sustained release steroid, demonstrated pain relief that is of both greater magnitude and longer duration than the most commonly prescribed immediate release steroid, triamcinolone acetonide (TCA IR), in a Phase 2b dose-ranging trial in osteoarthritis (OA). Top-line results for FX006 include:

• The optimal  dose of FX006 showed a statistically significant and clinically meaningful improvement in the magnitude and duration of pain relief relative to TCA IR
• FX006 was very well-tolerated and the systemic exposure produced by FX006 was substantially less than that of TCA IR
• All secondary measures including functional assessment, responder status, patient global impression of change, clinical global impression of change and rescue medicine consumption demonstrated significant improvement compared to TCA IR
• Onset of pain relief occurred within hours to days--as rapid as TCA IR

"It's not often we see a pain relief signal in osteoarthritis clinical trials as dramatic as the one seen with FX006," said Matt Provencher, M.D., chief, Sports Medicine Service, Massachusetts General Hospital, Harvard Medical School. "Immediate release steroids are currently front-line intra-articular therapy for patients with degenerative conditions of the knee. With the magnitude and durability of both pain relief and improvement in function seen in this trial, FX006 has the potential to become the new front-line standard-of-care for patients with knee osteoarthritis."

Michael Clayman, M.D., co-founder and chief executive officer of Flexion, added, "Flexion's drug candidates are designed to provide safe and long lasting benefit using sustained release therapies delivered locally to the site of disease. These data, together with earlier Phase 2a data for FX006 and for FX005, validate our intra-articular, sustained release strategy, and provide a high level of confidence as FX006 progresses toward pivotal Phase 3 trials. We expect to initiate these trials early in 2014."

The Phase 2b trial 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. Efficacy was evaluated using the weekly mean of the average daily pain intensity score (on the 0 – 10 Numeric Rating Scale) at weeks 1 through 12.