FDA asks for more da­ta from Opti­nose, ex­tends re­view time for nasal spray

The FDA has asked Opti­nose for more in­for­ma­tion from one of the piv­otal clin­i­cal tri­als of its nasal polyps spray Xhance, the com­pa­ny an­nounced Wednes­day, de­lay­ing its hopes to ex­pand the drug’s in­di­ca­tion in­to chron­ic si­nusi­tis.

The agency is ask­ing for ad­di­tion­al ef­fi­ca­cy analy­ses of a sub­group of pa­tients in Opti­nose’s Re­Open1 study, which in­clud­ed chron­ic si­nusi­tis pa­tients both with and with­out nasal polyps. A de­ci­sion on the la­bel ex­pan­sion had been ex­pect­ed by Dec. 16, but that dead­line will now be pushed to March 16, 2024.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.