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. Compared to the those who received an Exhalation Delivery System placebo, the patients who received Xhance Exhalation Delivery System in the ReOpen1 clinical trial was found to meet the co-primary endpoints, 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. The results could lead Optinose (OPTN) to secure the regulatory approval for XHANCE potentially making it the first U.S.-licensed drug for chronic sinusitis. ReOpen1 is one of two late-stage trials the company is conducting for the indication, the results of
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Optinose says late-stage trial for Xhance in Sinusitis met key goals