12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps

Trial Profile

12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2018

At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Sinusitis
  • Focus Adverse reactions; Registrational
  • Acronyms EXHANCE-12
  • Sponsors OptiNose
  • Most Recent Events

    • 05 Mar 2018 Results of pooled data from EXHANCE-3 and EXHANCE-12 assessing Exhalation Delivery System with Fluticasone treatment outcomes for CRSsNP patients with and without a recent INS, were presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 18 Sep 2017 According to an OptiNose media release, the U.S. Food & Drug Administration (FDA) approved the Company's New Drug Application (NDA) for XHANCE for the treatment of nasal polyps in patients 18 years of age and older.
    • 09 May 2017 According to a OptiNose media release, The FDA has set a target date to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) of September 2017.
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