Flexion Therapeutics Announces Upcoming Presentations at the 2019 Osteoarthritis Research Society International (OARSI) World Congress
Repeat Administration of Triamcinolone Acetonide Extended-Release Affords Consistent, Clinically Relevant Improvements in Pain: Results from a Phase 3b, Single-Arm, Open-Label Study (Poster 732)
- Safety and Systemic Exposure of Triamcinolone Acetonide Following Intra-Articular Injection of Triamcinolone Acetonide Extended-Release or Standard Triamcinolone in Patients with Hip Osteoarthritis (Poster 731)
- Dose-Dependent Chondroprotective Effects of Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an In Vitro Model (Poster 230)
- Flexion sponsored Satellite Lunchtime Symposia, “Considerations in the Chronic Management of Osteoarthritis” to be held today at
11:30 a.m. ET
“As a company focused on advancing innovative, local therapies for the treatment of osteoarthritis (OA), the
Flexion data presented at the 2019
- Repeat administration of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) tailored to patient symptoms was generally safe and well-tolerated, had no deleterious effect on cartilage or joint structure per x-ray, and resulted in substantial improvements in OA symptoms after both injections; and
- More than 60% of patients demonstrated a substantial analgesic response with ≥50% improvement from baseline in WOMAC-A (pain), WOMAC-B (stiffness), WOMAC-C (function), or KOOS-QoL score after both the first and second injections of ZILRETTA.1,2
Safety and Systemic Exposure of Triamcinolone Acetonide Following Intra-Articular Injection of Triamcinolone Acetonide Extended-Release or Standard Triamcinolone in Patients with Hip Osteoarthritis (Poster 731)
- ZILRETTA was generally safe and well-tolerated, and there were no serious adverse events (AEs) or AEs leading to treatment discontinuation;
- No study drug related AEs occurred in the ZILRETTA treatment group.
- The PK profile of ZILRETTA observed in the hip was consistent with previous PK studies in the knee showing some systemic absorption and a plateau in plasma triamcinolone acetonide (TA) concentration through Hour 24, followed by gradual systemic elimination; and
- ZILRETTA injection into the hip resulted in lower peak plasma levels and reduced systemic exposure relative to triamcinolone acetonide crystalline suspension, a pattern similarly observed in knee OA.
Dose-Dependent Chondroprotective Effects of Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an In Vitro Model (Poster 230)
- In an in vitro model, the administration of pro-inflammatory cytokines and/or mechanical injury to cartilage explants resulted in a reduction of cartilage matrix biosynthesis and an increase in cartilage matrix breakdown; and
- The administration of TA in inflamed and/or injured cartilage tissue had protective effects, such as restoration of cartilage matrix biosynthesis and prevention of cartilage matrix breakdown, and no detrimental effects were observed at any dose in inflamed or injured cartilage.
- The study was led by Professor Alan Grodzinsky, Sc.D., Director of the Center for Biomedical Engineering at the
Massachusetts Institute of Technology.
Flexion will also sponsor a lunchtime satellite symposium entitled, “Considerations in the Chronic Management of Osteoarthritis” today at
Indication and Select Important Safety Information for ZILRETTA
Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with
Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZilrettaLabel.com for full Prescribing Information.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million adults living in the U.S. and accounts for more than
This release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; ZILRETTA's market potential and potential benefits; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of ZILRETTA, are forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with developing and obtaining regulatory approval for product candidates; the fact that results of past clinical trials may not be predictive of subsequent trials; risks associated with commercializing new pharmaceutical products in
1. WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints.
2. The KOOS (Knee Injury and Osteoarthritis Outcome Score) QoL (Quality of Life) subscale Assesses patients' perceptions about their treated knee and associated problems related to quality of life.
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Source: Flexion Therapeutics, Inc.