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XHANCE significantly reduced both symptoms and sinus opacification in participants with chronic sinusitis (chronic rhinosinusitis) in two randomized controlled Phase 3 Clinical Trials (ReOpen1 and ReOpen2)
FDA Supplemental New Drug Application Filed with Prescription Drug User Fee Act Target Goal Date of March 16, 2024
YARDLEY, Pa., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced peer-reviewed publication of results from both ReOpen1 and ReOpen2 in the Journal of Allergy and Clinical Immunology: In Practice1.
The ReOpen program evaluated XHANCE for treatment of adults with chronic sinusitis (chronic rhinosinusitis). A drug-device combination product, XHANCE® (fluticasone propionate) nasal spray uniquely combines a widely used nasal anti-inflammatory drug with the Exhalation Delivery System™, an innovative delivery system designed to deliver the medication high and deep into difficult-to-access sinuses and sinonasal drainage tracts.
"Patients with chronic sinusitis often suffer for years and may use multiple over-the-counter treatments in a search for ways to alleviate their symptoms. The burden of chronic sinusitis has been measured and is serious, with a degree of impaired quality of life and functioning comparable to other serious chronic conditions such as chronic heart failure, sciatica, or migraine. Chronic sinusitis is also common: data suggests it is one of the top diagnoses in adult outpatient physician visits. Although surgery is available, there has never been a medication approved by the FDA as safe and effective for this disease," said Ramy Mahmoud, MD, MPH, CEO of Optinose. "Having a proven effective medication would finally allow doctors to have confidence that they can offer some relief to tens of millions of people suffering from this burdensome inflammatory condition."
As detailed in the new scientific publication Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2), both trials showed statistically significant improvement in symptoms, and in inflammation inside the sinuses, in patients with chronic sinusitis (chronic rhinosinusitis) treated with XHANCE compared to patients receiving a vehicle combined with the Exhalation Delivery System (EDS-placebo). The primary endpoints include a composite symptom score (congestion, facial pain or pressure, and nasal discharge) 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 (incidence ≥ 3%) in the ReOpen program were epistaxis, headache, and nasopharyngitis.
"With the help of patients and doctors in many countries, after years of effort, we are thrilled to see that results from these two pivotal trials are now available in a peer reviewed publication. Not only do these data support the sNDA we filed with FDA in 2023," stated John Messina, PharmD, Senior Vice President of Clinical Research and Medical Affairs, "but they represent the first body of large, controlled trial evidence we are aware of showing that any nasal medication can produce improvement in symptoms and can reduce inflammation inside the sinus cavities of patients suffering from chronic sinusitis either with or without concurrent nasal polyps. Our team is proud of this breakthrough in the treatment of chronic sinusitis, and we sincerely thank the healthcare professionals who advised us along the way as well as those at our research sites and all the patients whose participation made this program possible."
Posted In: OPTN
