OptiNose, Inc. announced the U.S. Food and Drug Administration (FDA) has approved XHANCE® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. Chronic sinusitis (also called ?chronic rhinosinusitis? or ?CRS?) is one of the most common chronic diseases, affecting approximately 30 million adults in the United States.

Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine. Chronic sinusitis is also one of the most common diagnoses in adult outpatient medicine. Chronic sinusitis is diagnosed in approximately 10 million outpatient visits, of which approximately 70% result in antibiotic prescriptions, and leads to more than 600,000 surgeries annually.

Although there are FDA?approved medications to treat nasal polyps, including XHANCE, no medication had ever been approved for the more than two-thirds of chronic sinusitis patients who do not have nasal polyps ? until March 15, 2024. The approval was based on data from the ReOpen program evaluating XHANCE for treatment of adults with chronic sinusitis.

A drug-device combination product, XHANCE uniquely combines a widely used nasal steroid with the Exhalation Delivery System?, an innovative delivery system designed to target the sites where inflammation occurs, especially difficult-to-access sinuses and sinonasal drainage tracts not typically reached by standard-delivery nasal sprays. The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile. The most common adverse reactions (incidence = 3%) in the ReOpen program were epistaxis, headache, and nasopharyngitis.