YARDLEY, PA — The U.S. Food and Drug Administration (FDA) recently approved XHANCE® (fluticasone propionate) nasal spray, developed by Optinose (NASDAQ: OPTN), for the treatment of chronic rhinosinusitis without nasal polyps in patients aged 18 and older. This approval marks a significant breakthrough for the estimated 30 million adults in the United States suffering from chronic sinusitis, a condition known to severely impair quality of life.
Chronic sinusitis ranks among the top diagnoses in adult outpatient medicine, leading to about 10 million visits annually. Approximately 70% of these visits result in antibiotic prescriptions, with more than 600,000 patients undergoing surgery each year. Despite the prevalence of this condition, until now, no FDA-approved medication existed for the majority of sufferers who do not have nasal polyps.
“The FDA approval of XHANCE for the treatment of CRS without nasal polyps is an important milestone,” said Rick Chandra, M.D., a leading expert at Vanderbilt University. He emphasized the historical reliance on unproven therapies and the efficacy of XHANCE, delivered via the Exhalation Delivery System™, in reaching the inflamed areas of the nasal cavity and sinuses.
Ramy Mahmoud, MD, MPH, CEO of Optinose, highlighted the challenges faced by those with chronic sinusitis, noting the frustration over symptom relief with standard-delivery nasal steroid sprays. “We are thrilled to now be able to offer new hope to these patients,” Mahmoud stated, underscoring the potential of XHANCE to redefine the standard of care for treating chronic sinusitis.
The FDA’s decision was based on data from the ReOpen program, which evaluated XHANCE’s effectiveness in adults with chronic sinusitis. As a drug-device combination product, XHANCE uniquely pairs a widely used nasal steroid with the Exhalation Delivery System™. This innovative delivery mechanism targets inflammation sites within the sinuses and sinonasal drainage tracts—areas often missed by conventional nasal sprays.
Adverse reactions observed in the ReOpen trials were generally consistent with the currently labeled safety profile for XHANCE, with the most common side effects being epistaxis, headache, and nasopharyngitis.
This FDA approval represents a pivotal advancement in the treatment of chronic sinusitis, offering millions of Americans a new and effective option for managing a condition that has long challenged both patients and healthcare providers.
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