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An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee

Trial Profile

An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee

Completed
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
  • Most Recent Events

    • 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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