Optinose announced that it has submitted an sNDA for a label expansion of Xhance fluticasone propionate nasal spray (OPN-375) for the treatment of chronic sinusitis without nasal polyps. Xhance has been approved for the treatment of nasal polyps in the US since 2017. In June 2022, the company announced that the second of two Phase 3 trials of Xhance for the treatment of chronic sinusitis met its primary endpoint.
Recently appointed Optinose CEO Ramy Mahmoud commented, “We are pleased to announce completion of this sNDA submission for Xhance. The submission marks an important milestone in our progress towards changing the standard of care for approximately 10 million people in the United States with chronic rhinosinusitis who seek physician treatment annually, particularly the majority who do not have nasal polyps and for whom there are currently no FDA-approved drug treatments. I would like to thank the patients whose altruism made this advance possible, and both the healthcare providers worldwide and my colleagues at Optinose whose hard work and dedication enabled the entire program and submission.”
Read the Optinose press release.
