A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction

Trial Profile

A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction

Completed
Phase of Trial: Phase III

Latest Information Update: 22 May 2017

At a glance

  • Drugs Mometasone (Primary) ; Steroids
  • Indications Sinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms RESOLVE
  • Sponsors Intersect ENT
  • Most Recent Events

    • 22 May 2017 According to an Intersect ENT media release, based on the data from this and RESOLVE II study the U.S. FDA has accepted the New Drug Application (NDA) for SINUVA steroid releasing sinus implant and set a PDUFA target action date of 7th January 2018.
    • 01 Jun 2016 Long-term (six-month) data from this trial published in the International Forum of Allergy and Rhinology journal, according to an Intersect ENT media release.
    • 29 Dec 2014 According to an Intersect ENT media release, RESOLVE II study is supported by data from this trial. Data from RESOLVE and RESOLVE II trials will support NDA submission to the US FDA.
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