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Objective   FX 006 is a novel, microsphere‐based, extended‐release formulation of triamcinolone acetonide for intraarticular ( IA ) injection designed to maintain treatment concentration in the joint and provide prolonged analgesic benefits in patients with osteoarthritis ( OA ) of the knee. This study was undertaken to compare the analgesic benefits of 2  FX 006 doses with saline placebo injection.    Methods  In this phase  II b study, participants with knee  OA  (Kellgren/Lawrence grade 2–3) and average daily pain ( ADP ) intensity ≥5 to ≤9 (on a 0–10 Numerical Rating Scale) were randomized (1:1:1) to receive single  IA  injections of  FX 006 32 mg (n = 104) or 16 mg (n = 102) or saline placebo (n = 100). The primary end point was the least squares mean ( LSM ) change from baseline to week 12 in weekly mean  ADP  intensity scores for  FX 006 32 mg versus saline placebo.    Results  The primary end point was not met ( LSM  change at week 12 −3.1 with  FX 006 32 mg versus −2.5 with saline placebo;  LSM  difference [95% confidence interval] −0.58 [−1.22, 0.07]) ( P  = 0.08). However, improvements in  ADP  intensity were significantly greater with  FX 006 32 mg than saline placebo at weeks 1–11 and week 13. Improvements in  ADP  intensity were significantly greater with  FX 006 16 mg versus saline placebo at weeks 1–9. A dose‐response effect in duration of maximal analgesic effect was evident (13 weeks with 32 mg versus 9 weeks with 16 mg), with  FX 006 32 mg providing increased therapeutic benefit relative to  FX 006 16 mg. All treatments were well tolerated.    Conclusion  Although the primary end point was not met, our findings indicate a prolonged reduction in symptoms with  FX 006 with an evident dose response and a safety profile similar to saline placebo.

arthritis and rheumatology

Brief Report: A Phase  II b Trial of a Novel Extended‐Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis