Xhance, a Drug/Device Combo Product, Under Review for Chronic Rhinosinusitis

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A PDUFA target date of December 16, 2023 has been set for the application.

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Xhance® (fluticasone propionate nasal spray) for the treatment of chronic rhinosinusitis.

Xhance is currently approved for the treatment of nasal polyps. The drug-device combination therapy delivers fluticasone, a corticosteroid, deep into difficult-to-access sinuses and sinonasal drainage tracts. The medication is delivered into the nose by actuating the pump spray into 1 nostril while simultaneously blowing (exhaling) into the mouthpiece of the device.

The sNDA is supported by data from the phase 3 ReOpen1 (ClinicalTrials.gov Identifier: NCT03781804) and ReOpen 2 (ClinicalTrials.gov Identifier: NCT03960580) trials, which included patients with chronic rhinosinusitis who were randomly assigned to receive Xhance or placebo over 24 weeks.

The coprimary endpoints were the change from baseline in symptoms as measured by a composite score of nasal congestion, facial pain or pressure sensation, and nasal discharge at the end of week 4, and the change from baseline in percent of ethmoid and maxillary sinus volume occupied by disease as measured by CT scan. 

Findings from ReOpen1 and ReOpen2 showed that treatment with Xhance was associated with a statistically significant improvement on both endpoints compared with placebo. The safety of Xhance was generally consistent with its known profile. 

“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,” said Ramy Mahmoud, MD, MPH, CEO of Optinose.

A Prescription Drug User Fee Act target date of December 16, 2023 has been set for the application.


Optinose announces FDA acceptance of supplemental New Drug Application for Xhance. News release. Optinose. Accessed May 4, 2023. https://www.globenewswire.com/news-release/2023/05/04/2661317/0/en/Optinose-Announces-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-XHANCE.html.