Positive topline results were announced from a phase 3 trial evaluating intranasal administration of OPN-375 (fluticasone propionate) in patients with chronic sinusitis without the presence of nasal polyps.
OPN-375 is currently marketed under the brand name Xhance® for the treatment of nasal polyps in patients 18 years of age and older. Xhance is a drug-device combination product that utilizes an Exhalation Delivery System to deliver the medication to deep regions of the nasal cavity. The medication is delivered into the nose by actuating the pump spray into 1 nostril while simultaneously blowing (exhaling) into the mouthpiece of the device.
The global, randomized, double-blind, placebo-controlled ReOpen2 trial (ClinicalTrials.gov Identifier: NCT03960580) included 222 patients with chronic sinusitis without nasal polyps. Patients were randomly assigned to receive 2 sprays of OPN-375 in each nostril twice daily or placebo over 24 weeks.
The coprimary endpoints were the change from baseline in symptoms as measured by a composite score of nasal congestion, facial pain or pressure sensation, and nasal discharge at the end of week 4, and objective change in inflammation inside the sinus cavities, as measured by the change in average of percentages of volume occupied by disease across the ethmoid and maxillary sinuses as measured by CT scan.
Results showed a statistically significant improvement for both endpoints with OPN-375 compared with placebo. The safety of OPN-375 was generally consistent with its known profile. Adverse events that occurred at a rate greater than 3% with OPN-375 and more common than placebo were epistaxis, COVID-19, headache, and depression.
“With top-line results showing that patients with chronic sinusitis experienced significant improvement in both symptoms and inflammation inside the sinuses, ReOpen2 confirms and builds on the positive results from ReOpen1 and, importantly, provides evidence supporting the effectiveness of Xhance in the very large chronic sinusitis population without nasal polyps,” said Ramy Mahmoud, MD, MPH, President of Optinose. “This program provides the first-ever body of controlled trial evidence we are aware of for a nasal medication to produce both improvement in symptoms and reduction of inflammation in the sinus cavities for patients suffering from chronic sinusitis regardless of the presence of nasal polyps.”
Optinose announces positive top-line results of ReOpen2, its second phase 3 clinical trial of XHANCE for treatment of chronic sinusitis. News release. Optinose. Accessed June 13, 2022. https://www.globenewswire.com/news-release/2022/06/13/2461040/0/en/Optinose-Announces-Positive-Top-line-Results-of-ReOpen2-its-second-Phase-3-Clinical-Trial-of-XHANCE-for-Treatment-of-Chronic-Sinusitis.html