Flexion Therapeutics Announces Publication of Data from Repeat Administration Trial of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in Rheumatology and Therapy
- Results from Phase 3b clinical trial indicate that repeat administration of ZILRETTA for osteoarthritis (OA) knee pain was generally safe and well-tolerated
- X-ray data at baseline and Week 52 showed ZILRETTA had no deleterious impact on cartilage or joint structure
- The majority (74%) of participants received their second injection at Week 16 or later and the magnitude of pain relief was similar for both injections
- Enrolled patients were approximately evenly distributed amongst Kellgren-Lawrence (KL) Grade 2, 3 and 4, and clinical benefit was similar across groups
“This valuable study suggests that repeat administration of ZILRETTA can provide patients suffering from knee OA consistent, substantial, and durable pain relief, and is generally well-tolerated. Importantly, analysis of the X-ray data showed no impact on cartilage or any other negative structural impact at one-year follow-up,” said
Key topline results from the Phase 3 trial:
- Repeat administration of ZILRETTA appeared safe and well-tolerated, with no serious adverse events or discontinuations related to ZILRETTA;
- The most commonly reported adverse events were consistent with those reported in previous clinical studies of ZILRETTA.
- X-rays conducted at baseline and Week 52 showed ZILRETTA had no deleterious impact on cartilage or joint structure and there were no observations of chondrolysis, osteonecrosis, insufficiency fractures or clinically significant subchondral bone changes;
- The median time to a second injection was 16.6 weeks, with 25.1%, 33.5%, 20.7% and 20.1% of patients receiving their second injection at Week 12, 16, 20 and 24, respectively; and
- Among those who received two injections, the magnitude and duration of clinical benefit after the first and second injections were similar with marked numeric improvements from baseline in pain scores observed when first assessed at four weeks.
- More than two-thirds of patients experienced a ≥50% reduction in WOMAC-A pain at Week 4 following both the first and second injection.
“We are excited to have these data published in a peer-reviewed journal, as they provide meaningful clinical evidence that repeat administration of ZILRETTA appears to provide safe and effective pain relief for the millions of people who confront ongoing pain from OA of the knee,” explained
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 the Repeat Administration Trial
The primary endpoint of the Phase 3b single-arm, open-label trial was the safety and tolerability of repeat administration of ZILRETTA in patients with symptomatic OA of the knee including those with advanced disease. More than two-thirds of the participants presented with Kellgren-Lawrence Grade 3 (37.5%) or Grade 4 (30.3%), the most radiographically severe form of OA.
Participants received an initial intra-articular injection of ZILRETTA followed by evaluation at Weeks 12, 16, 20 and 24 to determine their eligibility for a second injection. A second dose was administered only when patients reported they were ready for additional treatment (based on pain levels) and their physician agreed it was clinically indicated. Clinical benefit was measured through validated instruments including the WOMACi questionnaire that evaluates a patient’s pain, stiffness and function, and the Knee Injury and Osteoarthritis Outcome Score-Quality of Life scale.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans 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; and expected increases in the rate of individuals with OA of the knee, 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, the risk that the sNDA is not approved or results in changes to the ZILRETTA label that are different than our expectations; whether any changes to the ZILRETTA label impact physicians’ willingness to prescribe ZILRETTA; risks associated with commercializing new pharmaceutical products in
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Source: Flexion Therapeutics, Inc.