Updated: FDA expands label for nasal spray to treat chronic sinus inflammation
18 Mar 2024
Drug Approval
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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Source: EndPoints
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