According to Optinose, the FDA has approved the company’s sNDA to extend use of Xhance fluticasone propionate nasal spray to include the treatment of chronic sinusitis without nasal polyps. Xhance was approved by the FDA for the treatment of nasal polyps in 2017. Optinose submitted the sNDA in February 2023. The FDA accepted the sNDA in May 2023 and set a PDUFA date in December 2023; however, the agency later requested additional information from Optinose and extended the goal date to March 16, 2024.
Optinose CEO Ramy Mahmoud commented, “People who don’t suffer from chronic sinusitis may not appreciate how burdensome the condition can be. More than 80% of patients with chronic sinusitis report frustration with symptom relief when using a standard-delivery nasal steroid sprays, and patients commonly use multiple unproven over the counter medications in an effort to find symptom relief. Although chronic sinusitis is one of the most common diagnoses in outpatient physician visits, and surgery is available, there has never been a prescription medication approved by the FDA as safe and effective to treat the millions of patients without nasal polyps suffering from this debilitating disease. We are thrilled to now be able to offer new hope to these patients and believe Xhance has the potential to become part of the standard of care for the treatment of chronic sinusitis.”
Read the Optinose press release.
