New Data Show XHANCE Benefits for Chronic Rhinosinusitis Patients

Optinose, a pharmaceutical company specializing in treatments for patients under the care of ear, nose, and throat (ENT) and allergy experts, has announced the publication of a new paper in the International Forum of Allergy & Rhinology. The paper, titled "EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials," explores the effectiveness of their product, XHANCE, in treating chronic rhinosinusitis (CRS).

Chronic rhinosinusitis, especially the type without nasal polyps, often fails to respond to topical medications. Unlike rhinitis, which can be effectively managed with standard nasal sprays, CRS requires more advanced treatments due to the difficulty in delivering medication to the sinus cavities. One of the roles of endoscopic sinus surgery (ESS) is to facilitate the delivery of drugs into these hard-to-reach areas.

XHANCE is a nasal spray utilizing the Exhalation Delivery System™ with fluticasone (EDS-FLU). This system creates unique airflow dynamics that allow corticosteroids to reach the sinus cavities and drainage pathways, proving effective in treating chronic sinusitis, also known as chronic rhinosinusitis without nasal polyps. The question arose whether this innovative delivery system's effectiveness varied between patients who had undergone sinus surgery and those who had not.

To address this, two 24-week trials, ReOpen1 and ReOpen2, were conducted. These studies compared the efficacy of XHANCE versus a placebo in patients with CRS, analyzing the results separately for those with and without prior sinus surgery. The results showed that XHANCE significantly improved symptoms, reduced sinus congestion, and enhanced the quality of life in both sets of patients. This indicates that previous sinus surgery is not a prerequisite for patients with CRS to benefit from XHANCE treatment.

Optinose, the company behind XHANCE, specializes in pharmaceutical solutions for ENT and allergy conditions. XHANCE is a combination drug-device product that delivers a topical steroid deep into the nasal cavity, targeting areas that are typically difficult to reach with standard sprays. The U.S. Food and Drug Administration has approved XHANCE for the treatment of both chronic rhinosinusitis without nasal polyps and chronic rhinosinusitis with nasal polyps for patients aged 18 and older.

It is important for patients to be aware of the safety information associated with XHANCE. Contraindications include hypersensitivity to any ingredient in the product. Potential adverse effects include local nasal reactions such as nosebleeds, ulcers, and nasal septum perforation. Patients should be periodically monitored for changes in the nasal mucosa, especially if they have recent nasal surgery or trauma. Long-term use may lead to conditions like glaucoma and cataracts, so referrals to ophthalmologists are advised if ocular symptoms develop.

Other serious reactions reported include hypersensitivity reactions, immunosuppression, and increased susceptibility to infections. High dosages or even regular doses in susceptible individuals may cause hypercorticism and adrenal suppression. Monitoring bone mineral density over time is also recommended.

The results from the ReOpen1 and ReOpen2 trials underscore the effectiveness of XHANCE regardless of prior surgical interventions, providing a significant therapeutic option for patients suffering from chronic rhinosinusitis.

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