Up­dat­ed: FDA ex­pands la­bel for nasal spray to treat chron­ic si­nus in­flam­ma­tion

The FDA on Fri­day signed off on a new in­di­ca­tion for Opti­nose’s nasal spray Xhance as a treat­ment for chron­ic rhi­nos­i­nusi­tis with­out nasal polyps in adults. Xhance first won FDA ap­proval in 2017 as a treat­ment for nasal polyps in adults, and its drug com­po­nent first won ap­proval in 1994.

The drug-de­vice com­bo prod­uct us­es a pro­pri­etary de­liv­ery sys­tem with a com­mon steroid, known as flu­ti­ca­s­one pro­pi­onate. Opti­nose said the ap­proval was based on a large place­bo-con­trolled tri­al that demon­strat­ed a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of symp­toms in chron­ic si­nusi­tis pa­tients with­out nasal polyps.

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