Reacting to the FDA Approval of Fluticasone Propionate Nasal Spray, with James Palmer, MD

The allergy community witnessed history on March 15, 2024 with the US Food and Drug Administration approval of fluticasone propionate nasal spray (XHANCE) for the treatment of chronic rhinosinusitis without nasal polyps in adult patients.

The first and only medication to receive this indication in agency history, the approval is based on data from the phase 3 ReOpen program and comes just more than a year after Optinose announced the submission of its supplemental new drug application to the FDA in February 2023.

“The FDA approval of XHANCE for the treatment of CRS without nasal polyps is an important milestone,” said Rick Chandra, MD, Professor of Otolaryngology-Head and Neck Surgery, Endowed Director, Roland “Ron” Eavey, MD, SM Endowed Directorship in Leadership and Education, Service Chief, Rhinology and Skull Base Surgery at Vanderbilt University.¹ “Until today, we have been forced to use unproven therapies to try and alleviate the symptoms that these patients suffer.

Approval of the agent for the latest indication is based on data from the ReOpen1 and ReOpen2 trials, which Optinose announced had been published in the Journal of Allergy and Clinical Immunology: In Practice in January 2024. Led by James Palmer, MD, the David W. Kennedy, MD Endowed Professor of Otorhinolaryngology and Director of Rhinology at the Perelman School, the publication offered an overview of the effects of fluticasone propionate nasal spray in the placebo-controlled trials, which examined adults with chronic rhinosinusitis irrespective of polyps (ReOpen1) and only adults with chronic rhinosinusitis without nasal polyps (ReOpen2), respectively.^2,3

Using the same composite symptom score in both trials as the primary endpoint, results demonstrated use of fluticasone propionate nasal spray provided significant benefit. Specifically, the composite symptom scores least-squares mean change for fluticasone propionate nasal spray 1 or 2 sprays per nostril was -1.58 and -1.60, respectively, compared to -0.62 with placebo (P for both < .001) in ReOpen1. In ReOpen 2, the composite least-squares mean change for fluticasone propionate nasal spray 1 or 2 sprays being -1.54 and -1.74, respectively, compared to -0.81 with placebo (P for both=.011).³

“This is the only option out there if you want to use an FDA-approved treatment for chronic sinusitis of all forms, with and without polyps. I think the thing where it's going to make the biggest difference is when I prescribe it for patients because our insurance company friends have a way of playing a shell game with us,” Palmer added, in an interview with HCPLive.

For more perspective on this approval and how it changes discussions around the management of chronic rhinosinusitis, check out our reaction interview with Palmer.

References:

1. Optinose. XHANCE approved by FDA as first and only medication indicated for treatment of adults with chronic rhinosinusitis without nasal polyps. Optinose. Accessed March 15, 2024. https://ir.optinose.com/news-releases/news-release-details/xhance-approved-fda-first-and-only-medication-indicated.
2. Optinose. Optinose announces the publication of reopen phase 3 clinical trial program evaluating XHANCE in the Journal of Allergy and Clinical Immunology: In Practice. Optinose. January 18, 2024. Accessed March 15, 2024. https://ir.optinose.com/news-releases/news-release-details/optinose-announces-publication-reopen-phase-3-clinical-trial.
3. Palmer JN, Adappa ND, Chandra RK, et al. Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2). J Allergy Clin Immunol Pract. Published online January 5, 2024. doi:10.1016/j.jaip.2023.12.016