OptiNose has announced positive results from the 24-week Phase 3 trial of OPN-375, an intranasal fluticasone product for the treatment for nasal polyps based on the company’s Bi-Directional Breath-Powered delivery system. The study showed statistically significant reduction in the primary endpoints, nasal congestion/obstruction symptoms as reported by patients and in polyp grade as measure by endoscopy, as well as in a number of secondary endpoints.
NAVIGATE II enrolled 323 patients who received either OPN-375 or placebo in a randomized, double-blind trial for 16 weeks, followed by an additional 8 weeks of treatment with OPN-375.
OptiNose President Ramy Mahmoud commented, “Chronic nasal inflammatory diseases are an extremely common, if underappreciated, problem and there is surprisingly little late-phase research to develop new treatments. Too many patients with these chronic diseases still have symptoms, despite the availability of current medications. We believe today’s results – if confirmed – could be an important step forward in meeting the needs of those patients who are suffering day in and day out with fairly severe symptoms. Our team has worked hard to develop OPN-375, and we are excited at the prospect of providing doctors with a potentially important new treatment option for these patients.”
Read the OptiNose press release.
