> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Review Extended on Sinus Drug
- URL: https://www.fdaweb.com/review-extended-on-sinus-drug/
- Published: 2023-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:17:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155934

FDA has extended by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis. The updated user fee review action target date is 3/16\. Currently, Xhance is indicated for treating chronic rhinosinusitis with nasal polyps.

The company says the review extension allows the agency more time to review FDA-requested additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA. “The additional efficacy subset analyses requested by the FDA evaluated the subgroup of patients in ReOpen1 consisting of patients without nasal polyps plus those patients with a nasal polyp grade of one or less at trial entry,” it says.

Xhance is described as a corticosteroid nasal spray (drug-device combination product) that combines a widely used nasal anti-inflammatory drug with the company’s Exhalation Delivery System, which is designed to deliver the drug high and deep into difficult-to-access sinuses and sinonasal drainage tracts.