Philip G Conaghan, David J Hunter, Stanley B Cohen, Virginia B Kraus, Francis Berenbaum, Jay R Lieberman, Deryk G Jones, Andrew I Spitzer, David S Jevsevar, Nathaniel P Katz, Diane J Burgess, Joelle Lufkin, James R Johnson, Neil Bodick
BACKGROUND: Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs. METHODS: In this Phase-3, multicenter, double-blinded, 24-week study, adults ≥40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ≥5 and ≤9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg)...
April 18, 2018: Journal of Bone and Joint Surgery. American Volume