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# OptiNose NDA for Nasal Polyposis Therapy Accepted
- URL: https://www.fdaweb.com/optinose-nda-for-nasal-polyposis-therapy-accepted/
- Published: 2017-01-31T12:00:00.000Z
- Updated: 2026-09-14T22:03:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137872

FDA has accepted for review an OptiNose NDA for OPN-375 and its use in treating nasal polyposis in adults. The company expects a user fee review action in September. The submission includes data from more than 1,500 patients and includes two global Phase 3 dose-ranging pivotal efficacy trials, NAVIGATE I and NAVIGATE II, which evaluated the safety and efficacy of OPN-375 compared to placebo in treating adults with bilateral nasal polyposis, the company says. It also includes data from two Phase 3 open-label clinical trials in adults with symptoms of chronic sinusitis with and without nasal polyps (EXHANCE-3 and EXHANCE-12), and a comparative bioavailability study.