A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa

Trial Profile

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2017

At a glance

  • Drugs Ciprofloxacin (Primary)
  • Indications Otitis externa
  • Focus Registrational; Therapeutic Use
  • Sponsors Otonomy
  • Most Recent Events

    • 18 Jul 2017 According to an Otonomy media release, the US FDA has accepted the supplemental NDA (sNDA) for the approval of OTIPRIO as a treatment of acute otitis externa (AOE) with a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018.
    • 04 May 2017 According to an Otonomy media release, based on the data from the study the company has recently submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA).
    • 05 Jan 2017 According to an Otonomy media release, the company plans to present the full results at an appropriate medical meeting in the future.
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