Phase III ReOpen2 trial of Xhance shows significant benefits in chronic sinusitis.
Optinose announced the statistically significant benefits of Xhance (fluticasone propionate nasal spray) in the phase III ReOpen2 trial for both the symptoms co-primary endpoint and the CT scan co-primary endpoint.
Significant improvement was demonstrated in patients with chronic sinusitis who did not have nasal polyps treated with both doses of Xhance nasal spray with the Exhalation Delivery System in the ReOpen2 clinical trial compared to patients receiving a vehicle Exhalation Delivery System (placebo).
The co-primary endpoints were a patient-reported composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) measured at week 4 and an objective measure of disease in the sinus cavities at week 24 (measured by average of the percentages of opacified volume on CT scan across the ethmoid and maxillary sinuses). The safety profile and tolerability of Xhance in this trial were generally consistent with its currently labelled safety profile.
Adverse events occurring at a rate of more than 3% with Xhance and more common than the Exhalation Delivery System placebo group in this trial were: epistaxis, COVID-19, headache, and depression. When pre-planned analyses are completed, detailed results from ReOpen2 will be submitted for publication in a peer-reviewed journal and for presentation at future medical meetings.
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