Optinose , a pharmaceutical company that focuses on treatments for ear, nose, and throat issues as well as allergies, has announced that the U.S. Food and Drug Administration has granted approval for XHANCE® (fluticasone propionate) nasal spray. This approval specifically applies to the treatment of chronic rhinosinusitis in patients aged 18 and older who do not have nasal polyps.

Chronic sinusitis, or chronic rhinosinusitis (CRS), affects approximately 30 million adults in the United States, making it one of the most prevalent chronic diseases. It significantly impacts quality of life, similar to conditions like chronic obstructive pulmonary disease, sciatica, or migraines. Chronic sinusitis ranks among the top diagnoses in adult outpatient medicine, with approximately 10 million outpatient visits annually. However, until now, there has been no FDA-approved medication for the majority of CRS patients who do not have nasal polyps.

The approval of XHANCE for CRS without nasal polyps is a significant milestone. Dr. Rick Chandra from Vanderbilt University underscores the importance of this achievement, noting the lack of proven therapies for this patient group prior to this approval. XHANCE, utilizing the Exhalation Delivery System, has demonstrated effectiveness in treating CRS patients, including those without nasal polyps.

Dr. Ramy Mahmoud, CEO of Optinose, highlights the burden of chronic sinusitis and the inadequacy of standard nasal steroid sprays for symptom relief, leading many patients to try multiple over-the-counter remedies. The approval of XHANCE offers new hope to millions of patients without nasal polyps and may potentially become a standard treatment for chronic sinusitis.

The approval is supported by data from the ReOpen program, which evaluated XHANCE for the treatment of chronic sinusitis. XHANCE, as a drug-device combination, combines a widely used nasal steroid with the Exhalation Delivery System, targeting inflamed areas within the nasal cavity and sinuses, including difficult-to-access regions.

The safety profile of XHANCE in the ReOpen trials remains consistent with its current labeling, with common adverse reactions including epistaxis, headache, and nasopharyngitis.

Optinose is committed to serving ENT and allergy specialist patients globally. For more information, please visit the company's website or follow them on X and LinkedIn.

XHANCE®, a drug-device combination, utilizes the Exhalation Delivery System™ (EDS®) to deliver a topical steroid to deep nasal cavity regions. FDA-approved for chronic rhinosinusitis treatment in patients aged 18 and above, XHANCE targets both polyp and non-polyp chronic rhinosinusitis cases.

 

Source: globenewswire.com

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