According to Optinose, the Phase 3 ReOpen1 trial of Xhance intranasal fluticasone propionate (OPN-375) in patients with chronic sinusitus met both of its primary endpoints, demonstrating statistically significant reduction in symptoms and in sinus inflammation measured by CT scan compared to placebo. A second Phase 3 trial, ReOpen2, is underway, with results expected in the second quarter of 2022. Xhance was approved by the FDA in 2017 for the treatment of nasal polyps.
Optinose President Ramy Mahmoud explained, “In ReOpen1, a large, international, controlled trial, we randomized 332 patients into the first of two trials studying Xhance for the treatment of patients with chronic sinusitis, a disease for which there are no FDA-approved drug treatments. In ReOpen1 we found that patients with chronic sinusitis who used Xhance improved, as measured by both a composite symptom score and as measured by the amount of inflammation in the sinuses themselves. ReOpen1 is exciting news for us and for tens of millions of people suffering from chronic sinusitis. Our team would like to thank the healthcare providers at our investigational sites, and especially the many patients with chronic sinusitis whose participation made this trial possible.”
Read the Optinose press release.
