Optinose has announced that the Phase 3 ReOpen2 trial of Xhance fluticasone propionate nasal spray (OPN-375) in patients with chronic sinusitis without nasal polyps demonstrated significant improvement compared to placebo in both patient reported symptoms at week 4 and inflammation measured by CT scan at week 24. The FDA approved Xhance in 2017 for the treatment of nasal polyps. Earlier this year, the company reported positive results from the ReOpen1 trial of Xhance in patients with chronic sinusitis.
Optinose President Ramy Mahmoud said, “ReOpen2 is a large, international, controlled trial, studying 222 patients with chronic sinusitis who did not also have nasal polyps. Currently there are no FDA-approved drug treatments for this large patient population. With top-line results showing that patients with chronic sinusitis experienced significant improvement in both symptoms and inflammation inside the sinuses, ReOpen2 confirms and builds on the positive results from ReOpen1 and, importantly, provides evidence supporting the effectiveness of XHANCE in the very large chronic sinusitis population without nasal polyps. This program provides the first-ever body of controlled trial evidence we are aware of for a nasal medication to produce both improvement in symptoms and reduction of inflammation in the sinus cavities for patients suffering from chronic sinusitis regardless of the presence of nasal polyps.”
Read the Optinose press release.
