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The FDA expanded the approval of fluticasone propionate (Xhance) nasal spray for chronic rhinosinusitis to also include treatment of adults without nasal polyps, manufacturer Optinose .

The drug-device combination product delivers the active ingredient, a topical steroid, to inflamed upper areas of the nasal cavity via an exhalation delivery system (EDS); roughly two-thirds of patients with chronic rhinosinusitis, or chronic sinusitis, do not have nasal polyps.

Support for the approval came from two phase III trials (ReOpen1 and ReOpen2) that tested the safety and efficacy of one or two doses of the EDS-fluticasone product daily for 24 weeks in over 500 patients with chronic rhinosinusitis.

The approval "is an important milestone," said study investigator Rick Chandra, MD, of Vanderbilt University in Nashville, Tennessee, in a statement from Optinose. "Until today, we have been forced to use unproven therapies to try and alleviate the symptoms that these patients suffer. While we often resort to using nasal steroid sprays in this patient population, they have never been shown to be effective in large placebo-controlled clinical studies."

In the ReOpen2 trial, which only included chronic rhinosinusitis patients without nasal polyps, treatment with EDS-fluticasone led to significant improvements in the study's coprimary outcomes: reductions on the composite symptom score (CSS) at week 4 and in ethmoid/maxillary sinus percent opacification at week 24.

Through 4 weeks, the least-squares (LS) mean change from baseline in CSS -- which sums scores for congestion, facial pain/pressure, and nasal discharge -- was -1.64 with EDS-fluticasone versus -0.81 for EDS-placebo (P<0.001). And for sinus percent opacification, as assessed by week-24 CT scans, patients had a LS mean change of -6.07 with fluticasone versus 1.19 with placebo (P<0.001).

In addition, acute disease exacerbations -- which frequently result in antibiotic prescriptions for this patient population and which was a key secondary endpoint of ReOpen2 -- were reduced by 56% to 66% with one or two sprays of fluticasone.

In pooled data from the two trials, adverse events (AEs) that occurred in at least 3% of patients and more often with fluticasone than placebo included epistaxis, COVID infection, headache, and nasopharyngitis.

To use the EDS system, patients place prongs of the device into each nostril to deliver the spray while simultaneously blowing into the device's mouthpiece to reach difficult-to-access sinuses and sinonasal drainage tracts.

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