First Patient Enrolled in Phase III Studies Using OptiNose’s Novel Breath Powered™ Device to Deliver Fluticasone Intranasally for Treatment of Nasal Polyps
Comprehensive clinical program is designed to support registration of OPN-375 (Fluticasone delivered with OptiNose’s Novel Breath Powered™ intranasal delivery device) in the United States and build on company’s mission to transform the static nasal drug delivery market
YARDLEY, Pa.—October 31, 2013—OptiNose Inc. announced today enrollment of the first patient into the NAVIGATE trials, two large phase III clinical trials of fluticasone delivered using OptiNose’s novel Breath Powered™ intranasal delivery system (OPN-375) for the treatment of nasal polyps. Building on the promising results of an earlier phase II study, which found a high degree of efficacy and even some polyp elimination1, NAVIGATE I & II are controlled trials designed to more definitively evaluate the efficacy and safety of three doses of fluticasone (100, 200, and 400 μg twice a day) delivered in a new way with the innovative OptiNose technology to treat patients with nasal polyps.
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