YARDLEY, Pa. - Optinose (NASDAQ:OPTN), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved XHANCE (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal polyps in patients 18 years and older.
Chronic sinusitis is a prevalent condition affecting around 30 million adults in the U.S., often leading to a significant number of outpatient visits and antibiotic prescriptions. Prior to this approval, no medication had been authorized specifically for the treatment of chronic sinusitis patients without nasal polyps.
The FDA's decision was based on the ReOpen program, which comprised two large, randomized, double-blind, placebo-controlled Phase 3 trials. These trials demonstrated a statistically significant reduction in symptoms and sinus inflammation, as well as a decrease in acute exacerbations often resulting in antibiotic use.
XHANCE utilizes the proprietary Exhalation Delivery System to deliver fluticasone, a proven steroid, to inflamed areas within the nasal cavity and sinuses that are not typically reached by standard nasal sprays.
The safety profile of XHANCE in the ReOpen trials was generally consistent with its currently labeled safety profile, with the most common adverse reactions being epistaxis, headache, and nasopharyngitis.
Dr. Rick Chandra, a Professor of Otolaryngology at Vanderbilt University, highlighted the importance of this approval, stating that until now, therapies used to alleviate symptoms in these patients were unproven. XHANCE's effectiveness in delivering the steroid to the targeted areas of inflammation offers a new treatment option for chronic sinusitis patients.
Optinose CEO, Ramy Mahmoud, expressed optimism about XHANCE becoming part of the standard of care for chronic sinusitis treatment. He also emphasized the burden of the disease on patients, many of whom report frustration with symptom relief when using standard-delivery nasal steroid sprays.
The approval of XHANCE expands its indications, as it was previously approved for treating chronic rhinosinusitis with nasal polyps. This new indication offers a potential solution for the majority of chronic sinusitis patients who do not have nasal polyps.
This article is based on a press release statement from Optinose, Inc.
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