FDA Approves First Nasal Spray for Chronic Rhinosinusitis Without Polyps

by Amy E. Hamaker •

The FDA recently expanded the approval of the XHANCE fluticasone propionate nasal spray manufactured by Optinose for chronic rhinosinusitis to also include treatment of adults aged 18 and older without nasal polyps.

Chronic rhinosinusitis is a very common chronic disease, affecting approximately 30 million adults in the United States. 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

XHANCE delivers the active ingredient, a topical steroid, to inflamed upper areas of the nasal cavity through an exhalation delivery system that targets the sites where inflammation occurs, especially difficult-to-access sinuses and sinonasal drainage tracts not typically reached by standard-delivery nasal sprays.

The FDA approval was based on data from the ReOpen I and II trials, global placebo-controlled clinical trials that evaluated the efficacy and safety of one or two sprays of XHANCE in each nostril twice daily, over 24 weeks, in 554 total patients with chronic sinusitis. The co-primary endpoints were a change from baseline in symptoms, as measured by a composite symptom score (nasal congestion, facial pain or pressure, and nasal discharge) at the end of week four and a change in inflammation inside the sinus cavities, as measured by CT scans (change in the average of the percentages of volume occupied by disease in the ethmoid and maxillary sinuses) at week 24. The ReOpen trials were the first to demonstrate a statistically significant reduction of symptoms in chronic sinusitis patients regardless of whether nasal polyps were present, and to show reduction in the number of acute exacerbations.

The safety profile and tolerability for patients in the ReOpen trials was generally consistent with its currently labeled safety profile. The most common adverse reactions (incidence ≥ 3%) in the trials were epistaxis, headache, and nasopharyngitis.