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A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps

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A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2024

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At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Chronic sinusitis; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms Re-Open 2
  • Sponsors OptiNose

    • Most Recent Events

    • 05 Sep 2024 According to OptiNose media release, the company announced the peer-reviewed publication of data from both ReOpen1 and ReOpen2 studies in the International Forum of Allergy & Rhinology, the journal of the American Rhinologic Society.
    • 15 Mar 2024 According to OptiNose media release, the company has announced the U.S. Food and Drug Administration (FDA) has approved XHANCE (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. approval is based on the data from ReOpen Program (ReOpen 1 and ReOpen 2).
    • 18 Jan 2024 According to an OptiNose media release, FDA Supplemental New Drug Application Filed with Prescription Drug User Fee Act Target Goal Date of March 16, 2024.

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