FDA approves first treatment for chronic rhinosinusitis without nasal polyps

FDA has approved fluticasone propionate (Xhance) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in adults ≥18 years of age. Previously, the drug-device combo had been approved for chronic rhinosinusitis with nasal polyps. According to the manufacturer, Xhance uses the proprietary Exhalation Delivery System that allows deposition of the corticosteroid in target areas of inflammation in difficult-to-access sinuses and sinonasal drainage tracts not typically reached by standard nasal sprays. Approval was based on data from the phase 3 ReOpen1 and ReOpen2 trials.