Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE


YARDLEY, PA — Optinose (NASDAQ: OPTN), a pharmaceutical company, this week 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.

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

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