According to Optinose, the FDA has accepted the company’s sNDA to expand the use of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps and has set the PDUFA target date for completion of its review as December 16, 2023. The FDA approved Xhance for the treatment of nasal polyps in 2017. Optinose submitted the sNDA in February 2023 based on data from the Phase 3 ReOpen1 and ReOpen2 trials.
Optinose CEO Ramy Mahmoud commented, “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. 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.”
Read the Optinose Pharmaceuticals press release.
