Flexion Therapeutics to Present Results from Phase 2 Trial Evaluating ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in Bilateral Knee OA at 2018 ACR Annual Meeting
- Data presented at 2018
American College of Rheumatology(ACR) Annual Meeting show concurrent, bilateral administration of ZILRETTA appeared safe and well tolerated
- Systemic exposure to triamcinolone acetonide was 10-fold lower with ZILRETTA compared to traditional immediate-release TAcs
- Four out of five people with osteoarthritis of the knee will eventually develop the disease in both knees
“Typically, physicians do not treat OA with corticosteroid injections in both knees at the same time due to concerns about potential systemic overexposure, which may require patients to return at a separate office visit to receive treatment in the second knee,” said
Key findings from the study showed:
- Exposure to triamcinolone acetonide was significantly lower in patients given ZILRETTA compared to those given TAcs, with maximum plasma concentrations nearly 10-fold lower (2,577.8 pg/mL compared to 24,289.4 pg/mL);
- Safety profiles were similar for ZILRETTA and TAcs treatment groups, and both treatments were generally well tolerated; neither bilateral injections of ZILRETTA nor TAcs resulted in prolonged decreases in systemic cortisol production; and
- There were no serious treatment emergent adverse events (TEAEs) and no patients discontinued the study.
The Phase 2 open-label study randomized 24 people with bilateral OA to receive concurrent injections of either ZILRETTA or TAcs in both knees. The most common TEAE related to study drug in patients given ZILRETTA was injection site pain (1 patient, 8.3%). In patients given TAcs, the most common TEAEs related to study drug were arthralgia (1 patient, 8.3%) and joint swelling (1 patient, 8.3%).
OA of the knee affects more than 15 million Americans, with many people experiencing chronic pain as the disease progresses. Bilateral OA of the knee is common and typically develops over time in people showing symptoms in one knee, with 80% developing pain in both knees after 12 years.
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 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; the proportion of knee OA patients that will eventually develop the disease in both knees; and expected increases in the rate of individuals with OA of the knee; the potential efficacy and safety profile of ZILRETTA for patients receiving bilateral injections, 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
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Source: Flexion Therapeutics, Inc.