Flexion Therapeutics Announces Presentation of Phase 3 Data at Military Health System Research Symposium
Military Health Systemprovides healthcare to more than nine million people; the research symposium highlights scientific advancements that impact military medicine
- Osteoarthritis is a leading cause of disability discharge from the military
- Post-hoc analysis showed those treated with ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) felt significant, sustained improvements in knee pain
OA of the knee affects more than 15 million Americans, including active-duty military personnel who are more likely to experience OA than those in non-tactical professions.1 Each year, approximately 11,000 active-duty service members are diagnosed with OA, which is also a leading cause of disability discharge due to the debilitating nature of the disease.1, 2
“The physically demanding nature of their work puts members of our armed forces at an increased risk of developing OA of the knee,” said
The MHSRS is the premier scientific meeting for the
The post-hoc analysis of patients with unilateral knee OA pain from the Phase 3 study demonstrated that ZILRETTA provided significant improvement in pain at Week 12 compared with placebo (P<0.0001) and immediate release triamcinolone acetonide (TAcs) (P<0.01). Those treated with ZILRETTA also appeared to have sustained response over placebo and TAcs with respect to improvements in pain, stiffness, and physical function at Weeks 4, 8, and 12 (measured through standardized, verified instruments; P<0.05 for all instruments).
These results were previously presented at the
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; expected increases in the rate of individuals with OA of the knee; the potential therapeutic and other benefits of ZILRETTA; and opportunities to obtain regulatory approval for further indications for 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
- Cameron KL, Driban JB, Svoboda SJ. Osteoarthritis and the tactical athlete: A systematic review. J Athl Train. 2016; 51(11).
- Cameron KL, Hsiao MS, Owens BD, Burks R, Svoboda SJ. Incidence of physician-diagnosed osteoarthritis among active duty
United Statesmilitary service members. Arthritis Rheum. 2011; 63(10): 2974-82.
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Source: Flexion Therapeutics, Inc.