Positive topline results were announced from a phase 3 trial evaluating the intranasal administration of OPN-375 (fluticasone propionate) in patients with chronic sinusitis with or without 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 (EDS) 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 ReOpen 1 trial (ClinicalTrials.gov Identifier: NCT03781804) included 332 patients with chronic sinusitis with or without nasal polyps. Patients were randomly assigned to receive OPN-375 186mcg or 372mcg 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 the change from baseline to week 24 in percent of ethmoid and maxillary sinus volume occupied by disease as measured by CT scan.
Findings demonstrated that treatment with OPN-375 met both coprimary endpoints demonstrating a statistically significant improvement compared with placebo. As for safety, adverse events that occurred at a rate greater than 3% with OPN-375 and more common than placebo were epistaxis, nasopharyngitis, asthma, and cataract (nuclear and cortical).
“ReOpen1 is the first pivotal registration trial I am aware of that shows significant effects on both subjective and objective endpoints in this disease,” said James Palmer, MD, past President of the American Rhinologic Society. “In particular, there are no prior phase 3 trials that show an intranasal drug treatment reduces inflammation inside the sinus cavities of people with chronic sinusitis.”
Full study results will be submitted for publication in a peer-reviewed journal and for presentation at future medical meetings.
The Company is also evaluating OPN-375 in patients with chronic sinusitis in the phase 3 ReOpen 2 trial (ClinicalTrials.gov Identifier: NCT03960580); topline results are expected in the second quarter of 2022.
Optinose reports positive top-line results in ReOpen1, a Landmark phase 3 trial for XHANCE in chronic sinusitis. News release. Optinose. Accessed March 7, 2022. http://ir.optinose.com/news-releases/news-release-details/optinose-reports-positive-top-line-results-reopen1-landmark