The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review.
The drug-device combination product Xhance nasal spray combines a nasal anti-inflammatory drug with an exhalation delivery system (EDS).
The EDS has been designed to deliver a topical anti-inflammatory high and deep into the sinuses and sino-nasal drainage tracts that are difficult to access.
The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.
If approved, Xhance will become the first and only drug to receive approval to treat chronic rhinosinusitis.
Optinose CEO Ramy Mahmoud stated: “Chronic sinusitis is one of the top diagnoses made in adult outpatient visits, with approximately 10 million physician office visits coded annually, yet there is a high level of patient dissatisfaction and suffering and no FDA-approved drug treatments except for patients who also have nasal polyps.
“We are excited to see our study data under FDA review as we believe the ReOpen trials found important benefits that Xhance could offer to physicians and their patients as a first-ever drug approved to treat chronic rhinosinusitis.”
The submission of the sNDA was based on data obtained from two Phase III clinical trials conducted in chronic sinusitis patients from the ReOpen Programme.
They demonstrated that Xhance significantly reduced both the symptoms of chronic rhinosinusitis and sinus opacification.
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