Optinose, a pharmaceutical company specializing in treatments for ear, nose, and throat (ENT) and allergy conditions, has announced that the US Food and Drug Administration (FDA) has granted approval for XHANCE® (fluticasone propionate) nasal spray. The approval covers the treatment of chronic rhinosinusitis (CRS) without nasal polyps in patients aged 18 years and older.

Chronic sinusitis, affecting around 30 million adults in the United States, is a prevalent chronic condition that significantly impacts patients' quality of life. Research indicates that its effects on quality of life are comparable to other serious chronic diseases like chronic obstructive pulmonary disease, sciatica, or migraine. Despite its prevalence, there has been a lack of FDA-approved medications for the majority of chronic sinusitis patients who do not have nasal polyps - until now.

Rick Chandra, M.D., Professor of Otolaryngology-Head and Neck Surgery at Vanderbilt University, emphasized the significance of XHANCE's approval for CRS without nasal polyps. “Until today, we have been forced to use unproven therapies to try and alleviate the symptoms that these patients suffer. While we often resort to using nasal steroid sprays in this patient population, they have never been shown to be effective in large placebo-controlled clinical studies. XHANCE, which uses the Exhalation Delivery System to enable the delivery of an established topical steroid to the areas of the nasal cavity and sinuses we know to be extensively inflamed, is now proven to be effective in treating our CRS patients both with and without nasal polyps,” he said.

Ramy Mahmoud, MD, MPH, CEO of Optinose, stressed the burdensome nature of chronic sinusitis and the frustration experienced by patients with standard nasal steroid sprays. XHANCE offers new hope to millions of patients suffering from this debilitating disease and has the potential to become part of the standard of care for chronic sinusitis treatment.

The FDA approval of XHANCE for CRS without nasal polyps was supported by data from the ReOpen program. This program evaluated XHANCE for adults with chronic sinusitis and demonstrated its effectiveness in targeting difficult-to-access sinuses and sinonasal drainage tracts. XHANCE combines a widely used nasal steroid with the Exhalation Delivery System, providing a unique treatment option for patients.

The safety profile of XHANCE, as observed in the ReOpen trials, was consistent with its existing safety profile. The most common adverse reactions reported were epistaxis (nosebleeds), headache, and nasopharyngitis (inflammation of the nose and throat).