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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2020

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At a glance

  • Drugs Ciprofloxacin (Primary)
  • Indications Otitis externa
  • Focus Registrational; Therapeutic Use
  • Sponsors Otonomy [CEASED]

    • Most Recent Events

    • 01 Jun 2019 Results assessing efficacy of Ciprofloxacin in patients with acute otitis externa, published in the Annals of Otology, Rhinology and Laryngology.
    • 02 Mar 2018 According to an Otonomy media release, the U.S. Food and Drug Administration (FDA) has approved OTIPRIO (ciprofloxacin otic suspension) 6% for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.
    • 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.

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