OptiNose Breathes Easy Following Data From Phase III Sinusitis Trial

OptiNose, a pharmaceutical company that creates treatments for allergy and ear, nose and throat conditions, announced positive top-line results from its Phase III ReOpen2 clinical trial testing OptiNose’s XHANCE, a fluticasone propionate nasal spray for chronic sinusitis. The results, which showed that XHANCE decreased facial pressure and nasal congestion, should help millions of people breathe easier—literally and figuratively.

In September 2017, OptiNose’s XHANCE was approved by the U.S. Food and Drug Administration to treat nasal polyps. XHANCE is a drug-device combination product that uses a delivery system to transport a topical anti-inflammatory corticosteroid to high and deep regions of the nasal cavity. Recently, the company began testing the same product to see if it can treat chronic sinusitis as well.

Chronic sinusitis (CS) is a health problem affecting as many as 30 million adults in the United States. People with CS have inflammation in the paranasal sinuses and the nasal cavity, preventing the cavities from draining properly and causing nasal discharge, facial pressure and facial pain. For the condition to be considered chronic, patients must experience symptoms for at least 12 weeks. Currently, there are no FDA-approved drugs for chronic sinusitis.

In March, OptiNose announced that ReOpen1—the first Phase III clinical trial testing Xhance as a treatment for chronic sinusitis—met both of its co-primary endpoints and showed a statistically significant improvement in patients with chronic sinusitis.

Now, OptiNose has announced positive data on a second Phase III clinical trial. The ReOpen2 clinical trial is a global, randomized, double-blind, placebo-controlled Phase III trial that involved 222 participants who suffer from chronic sinusitis but who do not have nasal polyps. In the trial, patients received one or two XHANCE sprays per day, or a vehicle exhalation delivery system as a placebo. The trial’s goal was to measure patients’ changes from the baseline over four weeks.

There were two ways the study measured patient changes: first, a patient reported symptoms such as nasal congestion, facial pain or pressure sensation, and nasal discharge, and second, a CT scan revealed any changes in the average volume occupied by the disease across the ethmoid and maxillary sinuses.

The results of the study showed patients with chronic sinusitis experienced significant improvement in both symptoms and inflammation inside the sinuses. Additionally, the safety and tolerability profile was in line with the currently labeled safety profile. Common adverse events included headache, epistaxis and depression.

“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,” Ramy Mahmoud, M.D., MPH, president of Optinose, said in a statement. “We believe these results are important to the tens of millions of people suffering from chronic sinus disease, so our team is working to quickly complete the analyses of both ReOpen1 and ReOpen2 and have begun the work necessary to seek a new indication that expands access to XHANCE for this broader group of patients.”

The company stated detailed results from ReOpen2 will be submitted for publication in a peer-reviewed journal and presented at future medical meetings.