Optinose announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis. The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024. On November 15, 2023, as part of the ongoing sNDA review, the FDA requested that Optinose submit additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA: ReOpen1.

Optinose submitted the requested analyses on November 22, 2023. On December 4, 2023, the FDA notified Optinose that it will require additional time to review this submission (which the FDA deemed a major amendment), and that the PDUFA goal date would be extended to March 16, 2024. 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.

XHANCE® (fluticasone propionate) nasal spray is a drug-device combination product that combines the most widely used nasal anti-inflammatory drug with the innovative Exhalation Delivery System? (EDS?). The EDS is designed to uniquely deliver drug high and deep into difficult-to-access sinuses and sinonasal drainage tracts.