OPTN - Optinose says late-stage trial for Xhance in sinusitis met key goals

The commercial-stage pharmaceutical company, Optinose (NASDAQ:OPTN) announced on Monday that its Phase 3 trial for Xhance (fluticasone propionate) met both primary endpoints with statistical significance in patients with chronic sinusitis. Comparing those who received an Exhalation Delivery System placebo, the patients who received Xhance Exhalation Delivery System in the ReOpen1 clinical trial were found to meet the co-primary endpoints of the trial measured based on benefits on symptoms and CT scans. XHANCE is currently approved in the U.S. to treat nasal polyps in patients 18 years of age or older. The safety and tolerability profile of the therapy was found to be consistent with that for currently-licensed indication, Optinose (OPTN) said. A potential regulatory approval for XHANCE in chronic sinusitis could make it the first U.S.-approved drug for the indication. ReOpen1 is one of two late-stage trials the company is conducting for the indication, and the results of the second

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Optinose says late-stage trial for Xhance in sinusitis met key goals