OPTN - Optinose gets FDA review for expanded use of Xhance for chronic rhinosinusitis
2023-05-04 09:16:53 ET
- The U.S. Food and Drug Administration (FDA) accepted for review Optinose's ( NASDAQ: OPTN ) application seeking expanded approval of Xhance to treat chronic rhinosinusitis (CR).
- CR can occur due to an infection by growth in the sinuses (nasal polyps) or by swelling of the lining of sinuses.
- Xhance (fluticasone propionate) nasal spray is a drug-device combination that uses the Exhalation Delivery System (EDS) is already approved in the U.S. to treat chronic rhinosinusitis with nasal polyps in patients 18 years of age or older.
- Optinose's supplemental new drug application (sNDA) was backed by data from two phase 3 trials in patients with chronic sinusitis from the ReOpen Program.
- The FDA is expected to make a decision by Dec. 16.
- If approved, Xhance is expected to be the first and only drug for treating chronic rhinosinusitis, according to the company.
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Optinose gets FDA review for expanded use of Xhance for chronic rhinosinusitis