NAVIGATE II: Trial Details

Pivotal efficacy and safety data for XHANCE have been published in the Journal of Allergy and Clinical Immunology

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NOTE: This scientific publication contains additional outcome measures and other information, including exploratory endpoints, not contained in the full Prescribing Information, which are subject to important limitations and require cautious interpretation.

NAVIGATE II was part of a comprehensive development program consisting of five clinical trials evaluating XHANCE in more than 1,500 adult patients, including two randomized, double-blind, placebo-controlled, Phase 3 pivotal clinical trials in adults with nasal polyposis (NAVIGATE I and NAVIGATE II) and two supportive open-label Phase 3 clinical trials in adults with symptoms of chronic sinusitis with or without nasal polyps (EXHANCE-3 and EXHANCE-12).^1-4

In NAVIGATE II, use of XHANCE resulted in significant improvement in both coprimary outcome measures: congestion/obstruction at Week 4 and mean change in bilateral polyp grade at Week 16.¹

Take a few minutes to explore the results of NAVIGATE II, which have recently been published in the Journal of Allergy and Clinical Immunology.

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References:

Leopold DA, Elkayam D, Messina JC, et al. NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis. J Allergy Clin Immunol. 2018; In press.
Palmer JN, Jacobson KW, Messina JC, et al. EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018; In press.
Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
Data on file. OptiNose US, Inc.

INDICATIONS

XHANCE is a corticosteroid indicated for the treatment of chronic rhinosinusitis with or without nasal polyps in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. 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 until healing
has occurred.
Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.
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 and infections can occur, including 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.
Assess for decrease in bone mineral density initially and periodically thereafter.

ADVERSE REACTIONS:

Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥ 3%) are epistaxis, headache, and nasopharyngitis.
Chronic rhinosinusitis with nasal polyps: 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.

Please see Full Prescribing Information pdf opensfull Prescribing Information, including Instructions for Use.

References:

Leopold DA, Elkayam D, Messina JC, et al. NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis. J Allergy Clin Immunol. 2018; In press.
Palmer JN, Jacobson KW, Messina JC, et al. EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018; In press.
Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
Data on file. OptiNose US, Inc.