YARDLEY, PA — Optinose (NASDAQ: OPTN), a Pennsylvania-based pharmaceutical company, has announced the publication of results from its ReOpen1 and ReOpen2 clinical trials. The findings, published in the reputable Journal of Allergy and Clinical Immunology: In Practice, demonstrate the effectiveness of XHANCE®, a drug-device combination product, in treating adults with chronic sinusitis.
Chronic sinusitis, or chronic rhinosinusitis, is a common condition that significantly impairs the quality of life for millions of people, often for years. Comparable in impact to chronic heart failure, sciatica, or migraine, it represents one of the top diagnoses in adult outpatient physician visits. Despite its prevalence, no medication had previously been approved by the FDA as safe and effective for this disease.
XHANCE uniquely combines a widely used nasal anti-inflammatory drug, fluticasone propionate, with the Exhalation Delivery System™, an innovative delivery system designed to reach difficult-to-access sinuses and sinonasal drainage tracts. The breakthrough comes as a major relief for patients who have long sought effective treatments for their symptoms.
The ReOpen clinical trials demonstrated statistically significant improvements in both symptoms and inflammation inside the sinuses for patients treated with XHANCE compared to those receiving a placebo combined with the Exhalation Delivery System. The primary endpoints of the trials included a composite symptom score (congestion, facial pain or pressure, and nasal discharge) and CT scans of the sinuses to objectively measure changes in inflammation inside the sinus cavities.
In addition to these primary outcomes, the trials also showed that XHANCE reduced the incidence of acute disease exacerbations by more than half. Furthermore, 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.
Regarding safety, the profile and tolerability of XHANCE for patients in the ReOpen trials were generally consistent with its currently labeled safety profile. The most common adverse reactions (incidence ≥ 3%) in the ReOpen program were epistaxis (nosebleeds), headache, and nasopharyngitis (cold symptoms).
The results from the ReOpen trials represent a landmark moment in the treatment of chronic sinusitis. As Optinose CEO Ramy Mahmoud, MD, MPH, noted, “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.”
This breakthrough promises to make a significant difference in the lives of those suffering from chronic sinusitis and underscores the importance of continued innovation in the healthcare industry. The success of XHANCE could pave the way for future advancements in the treatment of this common but often overlooked condition.
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