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: 28 Sep 2017

At a glance

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

    • 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.
    • 31 Jan 2017 According to an OptiNose media release, the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for the investigational new product OPN-375.
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