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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jan 2024

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At a glance

  • Drugs Triamcinolone (Primary)
  • Indications Osteoarthritis
  • Focus Adverse reactions; Registrational
  • Sponsors Flexion Therapeutics; Pacira BioSciences

Most Recent Events

  • 01 May 2020 According to a Flexion Therapeutics media release, data from this study was accepted as abstracts at Osteoarthritis Research Society International (OARSI) OARSI 2020 and published in the Osteoarthritis & Cartilage journal.
  • 01 May 2020 Results published in the Flexion Therapeutics media release
  • 14 Oct 2019 According to a Flexion Therapeutics media release, the anticipated Prescription Drug User Fee Act (PDUFA) action date was today, October 14, 2019 however the U.S. Food and Drug Administration (FDA) has informed the company it needs additional time to complete the review of the supplemental New Drug Application (sNDA) for ZILRETTA (triamcinolone acetonide extended-release injectable suspension) and the review is expected to be completed in the coming weeks.

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