Clinical Trials and Associated Publications

 

ONGOING CLINICAL TRIALS

Study to assess the safety of repeat administration of FX006 administered to patients with osteoarthritis of the knee. NCT03046446

 

PUBLICATIONS
Efficacy and Safety

Conaghan P, et al. An intra-articular, extended-release formulation of triamcinolone (FX006) affords clinically relevant improvements in pain and function of knee osteoarthritis: post hoc pooled analyses of three randomized controlled trials. Osteoarthritis Cartilage. 2017; 25 (Supplement 1):S432-S433. NCT01487161, NCT02116972, NCT02357459

Spitzer A, et al. Intra-articular injection of an extended-release formulation of triamcinolone acetonide provided significant improvement in pain, stiffness and function in patients with knee osteoarthritis. Presented as an oral at the AAHKS Annual Meeting, Friday, November 11, 2016. Paper #8. NCT02357459

Conaghan P, et al. Sustained and profound analgesic benefits in people with osteoarthritis of the knee using FX006, an intra-articular extended-release formulation of triamcinolone acetonide: Results from a double-blind, randomized, parallel-group, dose-ranging study. Osteoarthritis Cartilage. 2016; 24:S49-S50. NCT02116972

Bodick N, et al. An intra-articular, extended-release formulation of triamcinolone acetonide prolongs and amplifies analgesic effect in patients with osteoarthritis of the knee: a randomized clinical trial. J Bone Joint Surg Am. 2015; 97(11):877-88. NCT01487161

HEOR

Kelley S, et al. An intra-articular, extended-release formulation of triamcinolone acetonide as a cost-effective therapy for treating osteoarthritis of the knee. Value Health. 2017; 20(5):A145. NCT01487161, NCT02116972, NCT02357459

Pharmacokinetics

Russell S, et al. In type 2 diabetes mellitus patients with knee osteoarthritis, intra-articular injection of FX006 (extended-release triamcinolone) is associated with reduced blood glucose elevation vs. standard triamcinolone: a randomized, blinded, parallel-group study. Diabetes. 2017; 66(Supplement 1):A289. NCT02762370

Byers-Kraus V, et al. Synovial and systemic pharmacokinetics of triamcinolone acetonide following intra-articular injection of an extended-release microsphere-based formulation (FX006) or standard crystalline suspension in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2017; 25 (Supplement 1):S431. NCT02637323

Nonclinical

Williamson T, et al. Systemic and local effects following intra-articular injection of FX006, an extended-release, PLGA microsphere formulation of triamcinolone acetonide: results from two nonclinical toxicity studies in dogs. Osteoarthritis Cartilage. 2017; 25(Supplement 1):S431-S432.

Kumar A et al. Sustained efficacy of a single intra-articular dose of FX006 in a rat model of repeated localized knee arthritis. Osteoarthritis Cartilage. 2015; 23(1):151-60.