Flexion provides IIR research grants within our therapeutic areas of expertise and based on the scientific merit of the concept and subsequent proposal. The research must be intended to contribute knowledge to the medical community. The budget must be reasonable and appropriate for the proposed work. In considering applications for support, Flexion will also consider the expertise of the proposed principal investigator and any sub-investigators, including their experience in the relevant therapeutic area, demonstrated ability to successfully conduct clinical trials, and available resources.
Your proposal will be considered by Flexion’s cross-functional research committee that meets routinely to review IIR proposals. Flexion may make suggestions to improve the scientific merit of the proposal and enhance consistency with Flexion’s support approval criteria described above, although as the study sponsor, the principal investigator will have full and final discretion and responsibility for all aspects of the study design, implementation, data analysis, and data dissemination, including compliance with all laws and regulations applicable to research sponsors. The terms under which Flexion will provide support must be contained in a written agreement. Flexion provides no guarantees that the research committee will provide support for your proposal.
To submit an IIR research proposal to Flexion, please click here to navigate to our new IIR inquiry page.
For questions related to submission of an investigator-initiated research concept, please contact your Regional Medical Scientific Director (RMSD) or email IIR@Flexiontherapeutics.com
Indication and Select Important Safety Information
Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.
Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.
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.
Other warnings and precautions for ZILRETTA and corticosteroids as a class include, alterations in endocrine function, cardiovascular and renal effects, increased intraocular pressure, GI perforation, alterations in bone density and behavior and mood disturbances.