Ongoing Clinical Trials
Triamcinolone Acetonide Extended-Release (TA-ER) Publications
Review Articles
Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee.
Paik J, et al. Drugs. 2019.
Clinical Trials - Efficacy and Safety
Phase 2/2b/3 Pooled – Single Administration
Rescue analgesic medication use by patients treated with triamcinolone acetonide extended-release for knee osteoarthritis pain: pooled analysis of three phase 2/3 randomized clinical trials.
Kivitz AJ, et al. Pain Ther. 2019.
Phase 3 – Post-Hoc
Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis.
Langworthy MJ, et al. Adv Ther. 2019.
Phase 3b – Repeat Administration
Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study.
Spitzer, AI, et al. Rheumatol Ther. 2019.
Phase 3 – Single Administration
Effects of a single intra-articular injection of a microsphere formulation of triamcinolone acetonide on knee osteoarthritis pain; a double-blinded, randomized, placebo-controlled, multinational study.
Conaghan PG, et al. J Bone Joint Surg Am. 2018.
Phase 2b – Single Administration
A phase IIb trial of a novel extended-release microsphere formulation of triamcinolone acetonide for intraarticular injection in knee osteoarthritis.
Conaghan PG, et al. Arthritis Rheumatol. 2018.
Phase 2 – Single Administration
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.
Bodick N, et al. J Bone Joint Surg Am. 2015.
Clinical Trials – Pharmacokinetics/Pharmacodynamics
Phase 2 – Single Administration
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 knee osteoarthritis.
Kraus VB, et al. Osteoarthritis Cartilage. 2018.
Phase 2 – Single Administration, Patients with Type 2 Diabetes
Triamcinolone acetonide extended-release in patients with osteoarthritis and type 2 diabetes: a randomized, phase 2 study.
Russell SJ, et al. Rheumatology (Oxford). 2018.
Nonclinical
Compatibility with Local Anesthetics – In Vitro Model
Physical and chemical compatibility of extended-release triamcinolone acetonide (TA-ER) with common local anesthetics.
Jackson JD, et al. Adv Ther. 2019.
Single and Repeat Administration – Canine Model
Local effects following single and repeat intra-articular injections of triamcinolone acetonide extended-release: results from three nonclinical toxicity studies in dogs.
Bodick N, et al. Rheumatol Ther. 2018.
Single Administration – Rat Model
Sustained efficacy of a single intra-articular dose of FX006 in a rat model of repeated localized knee arthritis.
Kumar A, et al. Osteoarthritis Cartilage. 2015.
2020
Effect of Triamcinolone Acetonide Extended-Release on Synovial Inflammation in Patients with Osteoarthritis of the Knee.
Kelley S, et al. American College of Sports Medicine Annual Meeting; May 26-30, 2020.
Patient and physician identified-factors guiding treatment choice in knee osteoarthritis and patient preference for intra-articular therapy.
Menon V, et al. International Society for Pharmacoeconomics and Outcomes Research Annual Meeting; May 16-20, 2020.
Prospective radiographic analysis of the effect of single and repeat administrations of intraarticular corticosteroids in knee osteoarthritis.
Jones DG, et al. American Medical Society for Sports Medicine Annual Meeting; April 24-29, 2020.
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OARSI 2020
Knee osteoarthritis specialists’ decisions and perceptions regarding treatment selection and patient experiences with intra-articular therapies.
Jones DG, et al. American Medical Society for Sports Medicine Annual Meeting; April 24-29, 2020.
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OARSI 2020
Sustained efficacy of intra-articular FX006 in a rat model of osteoarthritis.
Kumar A, et al. Osteoarthritis Cartilage. 2012;20(suppl 1):S289. Abstract 576.A thousand patient voices: knowledge, impact, and experiences of living with osteoarthritis of the knee.
Jones DG, et al. American Medical Society for Sports Medicine Annual Meeting; April 24-29, 2020.
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OARSI 2020
Fitbit®-derived evidence of enhanced mobility of patients with knee osteoarthritis treated with triamcinolone acetonide extended release: results from a phase 3B, single-arm, open-label study.
Huffman KM, et al. American Medical Society for Sports Medicine Annual Meeting; April 24-29, 2020.
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OARSI 2020
ACSM 2020
A real-world survey of patients’ experience and satisfaction with intra-articular triamcinolone acetonide extended-release for the management of osteoarthritis of the knee.
Menon V, et al. Academy of Managed Care Pharmacy Annual Meeting; April 21-24, 2020.
Cost-effectiveness Analysis of One Year’s Management of Symptomatic Osteoarthritis of the Knee with Extended-Release Triamcinolone Acetonide Versus Hyaluronic Acid.
Kelley S, et al. Academy of Managed Care Pharmacy Annual Meeting; April 21-24, 2020.
2019
A phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of triamcinolone acetonide extended-release in patients with hip osteoarthritis.
Mont M, et al. American Association of Hip and Knee Surgeons, November 7-10, 2019.
Extended-Release Triamcinolone Acetonide Enhanced Magnitude and Duration of Pain Relief Compared with Conventional Triamcinolone in Patients with Confirmed Moderate-to-Severe Knee Osteoarthritis.
Jones D, et al. American Association of Hip and Knee Surgeons, November 7-10, 2019.
Initial/Repeat Triamcinolone Acetonide Extended-Release (TA-ER) Reduces Osteoarthritis Knee Pain Regardless of Prior Intra-Articular Corticosteroids.
Huffman K, et al. American College of Sports Medicine Annual Meeting; May 28-June 1, 2019.
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SOA 2019
WOA 2019
Safety and systemic exposure of triamcinolone acetonide following intra-articular injection of triamcinolone acetonide extended-release or standard triamcinolone in patients with hip osteoarthritis.
Kivitz A, et al. OARSI World Congress on Osteoarthritis; May 2-5, 2019.
Repeat administration of triamcinolone acetonide extended-release affords consistent, clinically relevant improvements in pain: results from a phase 3b, single-arm, open-label study.
Gomoll A, et al. OARSI World Congress on Osteoarthritis; May 2-5, 2019.
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AOSSM 2019
Repeat Triamcinolone Acetonide Extended-Release in Patients With Bilateral or Unilateral Osteoarthritis (OA).
Richmond J, et al. American Medical Society for Sports Medicine; April 12-17, 2019.
Concordance of baseline pain measures (across two reporting instruments) influences treatment effect of extended-release triamcinolone: Phase 3 post-hoc sensitivity analysis.
Ross E, et al. American Pain Society Annual Meeting; April 3-6, 2019
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ACR 2019
PAINWeek 2019
AMSSM 2020
OARSI 2020
WOA 2020
Impact of Intra-Articular Corticosteroid Injections on Opioid Utilization Patterns in Patients with Knee Osteoarthritis.
Yeaw J, et al. Academy of Managed Care Pharmacy; March 25-28, 2019.
Dose-Dependent Chondroprotective Effects of Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an In Vitro Model.
Frank E, et al. Orthopaedic Research Society; February 2-5, 2019.
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OARSI 2019
2018
Triamcinolone acetonide extended-release injectable suspension (TA-ER) provides clinically relevant improvements in pain and function of knee osteoarthritis: a pooled analysis of 3 randomized clinical trials employing composite assessments.
Katz NP, et al. Osteoarthritis Cartilage. 2018;26(suppl 1):S232-S233.
Assessment of the safety of repeat administration of triamcinolone acetonide extended-release injectable suspension in patients with knee osteoarthritis: trial design, methods and preliminary data.
Spitzer AI, et al. Osteoarthritis Cartilage. 2018;26(suppl 1):S251-S252.
Cost effectiveness analysis of intra-articular triamcinolone acetonide extended-release injectable suspension (TA-ER) versus triamcinolone acetonide crystalline suspension for symptomatic knee osteoarthritis.
Kelley SD, et al. Value Health. 2018;21(suppl 1):S197-S198.
Assay sensitivity of average daily pain (ADP) and Western Ontario and McMaster Osteoarthritis Index A-pain (WOMAC-A) in a phase 3 trial of intra-articular FX006 for osteoarthritis knee pain.
Katz N, et al. J Pain. 2018;19(3);S76. Abstract 262.
Efficacy of triamcinolone acetonide extended-release injectable suspension in patients with unilateral knee osteoarthritis.
Ruane JJ, et al. J Managed Care Pharm. 2018;24(4-a):S88-S89.
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Military Health Systems Research Symposium
Systemic exposure of triamcinolone acetonide following bilateral injection of extended-release triamcinolone acetonide and standard triamcinolone in patients with bilateral knee osteoarthritis.
Kivitz A. et al. Arthritis Rheumatol. 2018;70(suppl 9). Abstract 1371.
Impact of prior intra-articular corticosteroid injections on the efficacy of FX006, an intra-articular extended-release formulation of triamcinolone acetonide, in patients with osteoarthritis of the knee: post-hoc, pooled analysis of three randomized controlled trials.
Spitzer A, et al. Annual Meeting of the American Academy of Orthopedic Surgeons; March 6-10, 2018.
Effects of an intra-articular, extended-release corticosteroid (FX006) treatment on health-related quality of life in patients with knee osteoarthritis: comparison with general population controls.
Rosen J, et al. Annual Meeting of the American Academy of Orthopedic Surgeons; March 6-10, 2018.
2017
Rescue medication usage by patients with osteoarthritis of the knee treated with triamcinolone acetonide extended-release (FX006): a post hoc, pooled analysis of three randomized controlled clinical trials.
Kivitz A, et al. Postgrad Med. 2017;129(suppl 1):S1-85. Abstract 92.
An intra-articular, extended-release formulation of triamcinolone acetonide as a cost-effective therapy for treating osteoarthritis of the knee.
Kelley SD, et al. Value Health. 2017;20(5):A145. Poster PMS28.
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.
Williamson TL, et al. Osteoarthritis Cartilage. 2017;25(suppl 1):S431-S432.
Synovial and systemic pharmacokinetics of triamcinolone acetonide following intra-articular injection of an extended release formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis.
Kraus VB, et al. Osteoarthritis Cartilage. 2017;25(suppl 1):S431.
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 3 randomized controlled trials.
Conaghan PG, et al. Osteoarthritis Cartilage. 2017;25(suppl 1):S432-S433.
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.
Russell SJ, et al. Diabetes. 2017;66(suppl 1):A289. Abstract 1091-P.
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OARSI 2018
Updating the knee osteoarthritis intra-articular corticosteroid meta-analysis with two large trials of extended-release triamcinolone acetonide (FX006) versus placebo.
Conaghan PG, et al. Arthritis Rheumatol. 2017;69(suppl 10). Abstract 1200.
Effectiveness of FX006 intra-articular injection in patients with knee osteoarthritis who present with and without clinical inflammation at baseline: a pooled analysis of data from 3 double-blind, randomized, parallel-group clinical trials.
Baraf HSB, et al. Arthritis Rheumatol. 2017;69(suppl 10). Abstract 934.
2016
In vitro degradation of compound A loaded PLGA microspheres.
Tipnis NP, et al. Presented at the 2016 American Association of Pharmaceutical Scientists Annual Meeting and Exposition; November 13-17, 2016.
Intra-articular injection of an extended-release formulation of triamcinolone acetonide provided significant improvements in pain, stiffness and function in patients with knee osteoarthritis.
Spitzer AI, et al. Annual Meeting of the American Association of Hip and Knee Surgeons; November 10-13, 2016.
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.
Conaghan PG, et al. Osteoarthritis Cartilage. 2016;24(suppl 1):S49-S50. Abstract 70.
2015
Prolonged joint residency of triamcinolone acetonide after an intra-articular injection of FX006, a sustained release formulation for the treatment of osteoarthritis.
Bodick N, et al. Osteoarthritis Cartilage. 2015;23(suppl 2):A360-361. Abstract 591.
2014
Safety and efficacy of FX006 in patients with osteoarthritis of the knee.
Bodick N, et al. Osteoarthritis Cartilage. 2014;22(suppl):S376-S377. Abstract 668.
A single intra-articular dose of FX006, an extended-release formulation of triamcinolone acetonide, has a similar effect on cartilage in healthy dogs as the commonly used kenalog-40® suspension.
Kumar A, et al. Osteoarthritis Cartilage. 2014;22(suppl):S463-S464. Abstract 848.
2013
A randomized, double-blind, dose ranging study comparing FX006, an intra-articular (IA) sustained-release formulation of triamcinolone acetonide (TCA), to an approved injectable suspension of TCA in patients with osteoarthritis (OA) of the knee.
Bodick N, et al. Arthritis Rheumatism. 2013;65(s10):S1138. Abstract 2668.
FX006 prolongs the residency of triamcinolone acetonide in the synovial tissues of patients with knee osteoarthritis.
Bodick N, et al. Osteoarthritis Cartilage. 2013;21(suppl):S144-S145. Abstract 267.
2012
Sustained efficacy of intra-articular FX006 in a rat model of osteoarthritis.
Kumar A, et al. Osteoarthritis Cartilage. 2012;20(suppl 1):S289. Abstract 576.
FX201 Publications
2021
Interim Data from the First-in-Human Phase 1 Trial of FX201, an Intra-Articular, Helper-Dependent Adenoviral Gene Therapy for Osteoarthritis - Safety, Tolerability, Biodistribution, and Preliminary Evaluation of Clinical Activity in 5 Patients.
Kelley S, et al. American Society of Gene and Cell Therapy (ASGCT) Annual Meeting;
May 11-14, 2021.
Presentation:
ASGCT 2021
2020
Establishing the efficacy, safety, and biodistribution of FX201, a helper-dependent adenoviral gene therapy for the treatment of osteoarthritis, in a rat model.
Senter R, et al. American Society of Gene and Cell Therapy (ASGCT) Annual Meeting; May 12-15, 2020.
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OARSI 2020
Development of a highly productive and reproducible manufacturing process for FX201, a novel helper-dependent adenovirus-based gene therapy for osteoarthritis.
Hong W, et al. American Society of Gene and Cell Therapy (ASGCT) Annual Meeting; May 12-15, 2020.
2019
The Rat Homolog to FX201, a Gene Therapy in Development for the Treatment of Osteoarthritis, Demonstrates Dose- Dependent Decreases in the Severity of Cartilage and Bone Lesions Following Anterior Cruciate Ligament Transection.
Senter R, et al. Arthritis Rheumatol. 2019;71(suppl 10). Abstract 1974.
2018
Interleukin-1 receptor antagonist gene therapy prevents and delays surgically-induced osteoarthritis in small and large animal models.
Grol MW, et al. Osteoarthritis Cartilage. 2018;26(suppl 1):S56-57.
FX301 Publications
2020
Efficacy and PK of peripheral nerve block by FX301, a novel Nav7 antagonist hydrogel, in a postoperative pain model in pigs.
Senter R, et al. American Society of Regional Anesthesia and Pain Medicine (ASRA) Annual Meeting; April 23-25, 2020.
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IARS 2020
ASA 2020
