Optinose announces 3-month extension of FDA review period for sNDA for XCHANCE

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. “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 morbidity and no FDA approved drug treatments for the majority of chronic sinusitis patients, those who do not have nasal polyps,” stated Ramy Mahmoud, MD, MPH, CEO of Optinose. “We believe the ReOpen trials demonstrated important clinical benefits XHANCE could offer chronic sinusitis patients and, if approved, we look forward to providing doctors and their patients the first-ever medication to treat all chronic sinusitis patients, including those with or without nasal polyps.”