Optinose reports publication of ReOpen Phase 3 trial results

Optinose announced peer-reviewed publication of results from both ReOpen1 and ReOpen2 in the Journal of Allergy and Clinical Immunology: In Practice. The ReOpen program evaluated XHANCE for treatment of adults with chronic sinusitis. A drug-device combination product, XHANCE nasal spray uniquely combines a widely used nasal anti-inflammatory drug with the Exhalation Delivery System, a delivery system designed to deliver the medication high and deep into difficult-to-access sinuses and sinonasal drainage tracts. As detailed in the new scientific publication Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials, both trials showed statistically significant improvement in symptoms, and in inflammation inside the sinuses, in patients with chronic sinusitis treated with XHANCE compared to patients receiving a vehicle combined with the Exhalation Delivery System. The primary endpoints include a composite symptom score and CT scans of the sinuses to objectively measure change in inflammation inside the sinus cavities. In additional statistically well-controlled measures, these trials also showed that XHANCE reduced the incidence of acute disease exacerbations by more than half and that treatment significantly reduced symptoms even for patients who entered the trials with symptoms despite using a standard-delivery nasal spray steroid, which are now generally available at prescription strength as over-the-counter treatments. The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile. The most common adverse reactions in the ReOpen program were epistaxis, headache, and nasopharyngitis.