An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee
Phase of Trial: Phase III
Latest Information Update: 17 Dec 2018
At a glance
- Drugs Triamcinolone (Primary)
- Indications Osteoarthritis
- Focus Adverse reactions; Registrational
- Sponsors Flexion Therapeutics
- 17 Dec 2018 According to a Flexion Therapeutics media release, based on the results of this study, the company has submitted the a supplemental new drug application (sNDA) to the U.S. FDA to revise the product label with new data indicating repeat administration of ZILRETTA was safe and well tolerated.
- 07 Nov 2018 Results presented in a Flexion Therapeutics Third-Quarter 2018 financial report.
- 07 Nov 2018 According to a Flexion Therapeutics media release, the trial results have been submitted for publication in a leading peer-reviewed journal and will form the basis of an sNDA which the Company plans to submit in the fourth quarter of 2018.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History