A 12-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of 400 microg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
Phase of Trial: Phase III
Latest Information Update: 09 May 2017
At a glance
- Drugs Fluticasone propionate (Primary)
- Indications Sinusitis
- Focus Adverse reactions; Registrational
- Acronyms EXHANCE-12
- Sponsors OptiNose
- 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.
- 16 Sep 2016 Results from this trial were presented at the American Rhinologic Societys Annual Meeting, according to an Optinose media release