OPTINOSE, INC. By Stephen Nakrosis
Optinose on Friday said the U.S. Food and Drug Administration approved Xhance as a treatment for certain patients with chronic rhinosinusitis.
Xhance, or fluticasone propionate, is the "first and only medication indicated for treatment of adults with chronic rhinosinusitis without nasal polyps," the pharmaceutical company said.
Optinose said the FDA based its approval on data from the ReOpen program, which was "the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps."
Optinose said chronic sinusitis, also known as chronic rhinosinusitis, affects about 30 million adults in the U.S. "Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine," the company said.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
03-15-24 1603ET
