New Peer-Reviewed Data Highlight the Benefits of XHANCE in Patients Who Remain Symptomatic After Treatment with Standard Nasal Steroid Sprays
First-line treatment for the 10 million patients who suffer with nasal polyps is often conventional, over the counter, inhaled steroids that were originally approved for allergic rhinitis (AR). But unlike AR, the nasal polyps associated with chronic rhinosinusitis start deep in the nasal cavity where nasal sprays usually do not reach. This analysis of data from the Phase 3 XHANCE studies showed comparable improvement across multiple outcome measures for patients receiving XHANCE, regardless of whether they were previously treated with a conventional inhaled nasal spray.
"It is very common for people suffering from symptoms of chronic rhinosinusitis, especially those with nasal polyps, to feel frustrated or experience persistent symptoms despite first-line treatment with standard conventional steroid nasal sprays," said
"Published treatment guidelines for chronic rhinosinusitis, including nasal polyps, call for treating first with inexpensive and relatively safe topically acting nasal steroids," said
"We are excited to see publication of this data that supports the value of XHANCE in the continuum of care," said
About the Study
This post-hoc analysis explored pooled data from the previously published NAVIGATE I and NAVIGATE II trials to compare the benefit of EDS-FLU vs EDS-placebo for the 45% of patients who reported use of a standard nasal steroid spray at study entry (median treatment duration of approximately 3 years) to the overall study population. Across multiple measures, including all 4 cardinal symptoms, patients who reported use of a standard nasal steroid spray at study entry were observed to have comparable improvement to patients who did not report prior use of conventional steroid nasal sprays at study entry.
About XHANCE (EDS-FLU)
EDS-FLU uses an Optinose Exhalation Delivery System (EDS) designed to deliver a topical anti-inflammatory corticosteroid to the high and deep regions of the nasal cavity where nasal polyps originate. Ten million patients suffer from nasal polyps which leads to approximately
Important Safety Information
CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local Nasal Effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma.
- Close monitoring for glaucoma and cataracts is warranted.
- Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
- Immunosuppression: potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
- Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.
DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.
INDICATION AND USAGE: XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
1- Senior BA, Schlosser RJ, Bosso J, Soler ZM. Efficacy of the exhalation delivery system with fluticasone in patients who remain symptomatic on standard nasal steroid sprays. Int Forum Allergy Rhinol. 2020 Sept 24. doi: 10.1002/alr.22693. [Epub ahead of print]
2- Bhattacharyya et al. Laryngoscope. 2019;129(9):1969-1975.
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