Investigating efficacy of extended-release steroid FX006 16mg and 32mg in knee OA treatment .
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A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis
Arthritis Rheumatol. 2018 Feb;70(2):204-211. doi: 10.1002/art.40364310 patients with Kellgren-Lawrence grade II-III knee osteoarthritis were randomized to a single intraarticular injection of either extended release triamcinolone acetonide 16mg (FX006 16mg; Flexion Therapeutics), extended release triamcinolone acetonide 32mg (FX006 32mg; Flexion Therapeutics), or placebo saline. Patients were assessed for the primary outcome measure of pain on a Numeric Rating Scale weekly for 24 weeks, with the primary endpoint at 12 weeks. At the primary endpoint, neither the FX006 16mg group nor the FX006 32mg group demonstrated significantly lower pain scores compared to the placebo group. At secondary endpoints, significantly lower NRS score was noted with FX006 16mg vs placebo for weeks 1-9, and with FX006 32mg vs placebo from weeks 1-11 and week 13. Differences between groups at all subsequent timepoints were not significant.
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