A phase III study for evaluating the RESOLVE steroid releasing implant for the treatment of recurrent sinus obstruction post-surgery in patients with chronic sinusitis, in the office setting

Trial Profile

A phase III study for evaluating the RESOLVE steroid releasing implant for the treatment of recurrent sinus obstruction post-surgery in patients with chronic sinusitis, in the office setting

Completed
Phase of Trial: Phase III

Latest Information Update: 22 May 2017

At a glance

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

    • 22 May 2017 According to an Intersect ENT media release, based on the data from this and RESOLVE 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.
    • 17 Oct 2016 Results published in the Intersect ENT Media Release.
    • 17 Oct 2016 Status changed from active, no longer recruiting to completed, according to Intersect ENT media release.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top