Optinose Announces Peer-Reviewed Publication of the Fourth Major XHANCE Registration Trial
“We are pleased to announce the publication of EXHANCE-3, the fourth major registration trial from the development program supporting the initial
EXHANCE-3 was part of a comprehensive development program including five clinical trials evaluating XHANCE® (fluticasone propionate) nasal spray in over 1,500 adult patients; including two randomized, double blinded, placebo controlled Phase 3 pivotal clinical trials in adults with nasal polyposis [NAVIGATE I and 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 -12]. Based upon the results of this program, the
EXHANCE-3 was a prospective, multicenter, 12-week, single-arm study evaluating the safety and efficacy of XHANCE 372 mcg twice daily in chronic sinusitis (CS) patients with or without nasal polyps. Eligible patients were 18 years of age or older and met diagnostic symptom criteria for CRS. In this study, 705 subjects were enrolled with 92.3% of patients reporting having previously tried corticosteroids and 27.5% reporting prior sinus surgery. All patients received XHANCE 372 mcg twice daily.
The majority of spontaneously reported AEs were local in nature, mild in severity, and resolved spontaneously with continued use of XHANCE. The most common AEs (>5%) included nasal mucosal disorder (10.2%), spontaneously reported epistaxis (6.8%), nervous system disorder (5.7%), and nasal septum disorder (5.5%).
Important efficacy measures in EXHANCE-3 included:
- Sinonasal Outcome Test‑22: At month 1, mean SNOT-22 total scores improved from baseline, with similar improvement in participants with nasal polyps or without nasal polyps of approximately 20 and 21 points, or 46% and 48% respectively. SNOT-22 scores improved more with longer duration of treatment through Month 3.
- Complete Response Analysis: After 3 months of treatment with XHANCE, approximately 48% of the patients who started the study with polyps were observed to have polyp elimination (polyp grade of zero) in at least one nostril.
- Patient Global Impression of Change: At month 3, 92% of patients with nasal polyps and 89% without nasal polyps reported improvement and 74% with nasal polyps and 68% without nasal polyps reported being ‘‘much’’ or ‘‘very much’’ improved.
Other efficacy measures indicating improvement in this study included Lund‐Kennedy endoscopic scoring of observed nasal pathology, indicators of potential need for surgery, and others.
About CRS with and without nasal polyps
Chronic rhinosinusitis (CRS) is a chronic inflammatory condition affecting an estimated 10%-15% of the population. Chronic rhinosinusitis is divided into two common subtypes: with or without nasal polyps (CRSwNP, CRSsNP). Nasal polyps are benign lesions developing from the chronically inflamed surfaces deep in the nose.
XHANCE (fluticasone propionate) nasal spray, 93 mcg is an exhalation delivery system combined with an anti-inflammatory corticosteroid and is currently indicated for the treatment of nasal polyps in patients 18 years of age or older. XHANCE combines a proprietary Optinose Exhalation Delivery System (
IMPORTANT SAFETY INFORMATION for XHANCE
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.
- Assess for decrease in bone mineral density initially and periodically thereafter.
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.
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.
INDICATIONS AND USAGE:
XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.
Please see full Prescribing Information at www.xhance.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the Company’s clinical program of XHANCE for chronic sinusitis; the potential for XHANCE to be the first
1 – Sher MR, Steven GC, Romett JL, Pien G, LeBenger K, Messina JC, Carothers JL, Mahmoud RA, Djupesland PG, EXHANCE-3: a cohort study of the exhalation delivery system with fluticasone for chronic sinusitis with or without nasal polyps, Rhinology, https://doi.org/10.4193/Rhin19.124.
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Source: Optinose, Inc.