Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE

Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE

Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) accepted for review its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis. 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. The sNDA submission is based on data from the two Phase 3 clinical trials in patients with chronic sinusitis from the ReOpen Program and has been assigned a Prescription Drug User Fee Act (PDUFA) target goal date of December 16, 2023.

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