Optinose has received approval from the US Food and Drug Administration (FDA) for its XHANCE nasal spray to treat chronic rhinosinusitis without nasal polyps.
Indicated for patients aged 18 years and above, XHANCE utilises the exhalation delivery system for the target delivery of fluticasone propionate, a topical steroid, to the deeper regions of the nasal cavity.
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The system is designed to reach areas affected by inflammation, particularly hard-to-reach sinuses and sinonasal drainage tracts.
The FDA’s decision was based on results from the ReOpen programme, which comprised two Phase III clinical trials.
These international, randomised, double-blind, placebo-controlled studies assessed the efficacy and safety of one or two sprays of XHANCE over a 24-week period.
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In the first trial, ReOpen1, 332 patients with chronic sinusitis, irrespective of the nasal polyps, received treatment.
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By GlobalDataThe second trial, ReOpen2, involved 222 patients without nasal polyps.
The change from baseline in symptoms at the end of fourth week and inflammation inside the sinus cavities at week 24 were the co-primary endpoints of the study.
XHANCE’s safety and tolerability in patients were found to be in line with existing data.
Epistaxis, headache and nasopharyngitis were the most frequently observed adverse reactions in the trial.
Optinose CEO Ramy Mahmoud stated: “More than 80% of patients with chronic sinusitis report frustration with symptom relief when using a standard-delivery nasal steroid sprays, and patients commonly use multiple unproven over the counter medications in an effort to find symptom relief.
“Although chronic sinusitis is one of the most common diagnoses in outpatient physician visits, and surgery is available, there has never been a prescription medication approved by the FDA as safe and effective to treat the millions of patients without nasal polyps suffering from this debilitating disease.”
