Optinose Announces Late Breaking Abstract Podium Presentation at IDWeek 2022
Presentation highlights a greater than 60% reduction in acute exacerbations and need for antibiotics for chronic sinusitis patients who used XHANCE in landmark ReOpen phase 3 clinical trial program
Acute exacerbations of chronic sinusitis can lead to doctor visits, antibiotic use, steroid use,
surgery, and important morbidity and loss of quality of life
There are approximately 10 million outpatient visits for chronic rhinosinusitis per year,
antibiotics are prescribed in ≈70% of visits, and chronic rhinosinusitis is reported to be the number one reason
for outpatient adult antibiotic prescriptions in
The ReOpen phase 3 clinical trial program evaluated XHANCE® (also referred to as EDS-FLU), as a potential treatment for chronic sinusitis. XHANCE (fluticasone propionate) nasal spray is a drug-device combination product combining OptiNose’s proprietary Exhalation Delivery System™ (EDS™) designed to uniquely deliver drug high and deep in nasal passages with an anti-inflammatory drug.
Late Breaking Presentation (LB1581): Exhalation Delivery System with Fluticasone (EDS-FLU) Significantly Reduces Acute Exacerbations and Associated Antibiotic Use in Chronic Rhinosinusitis, is scheduled for
This presentation is intended for scientific discussion only.
About the ReOpen Program
The ReOpen program comprises two global, randomized, double-blind, placebo-controlled Phase 3 trials that evaluated the efficacy and safety of one or two sprays of XHANCE (OPN-375) in each nostril twice daily, over 24 weeks, in patients suffering from chronic sinusitis (CS). In ReOpen1, the first of the two trials, 332 patients were treated who had CS with or without nasal polyps. In ReOpen2, the second of the two trials, 222 patients were treated who had CS without nasal polyps. The co-primary endpoints were change from baseline in symptoms, as measured by a composite score of patient-reported symptoms (including nasal congestion, facial pain or pressure sensation, and nasal discharge) at the end of week 4, and objective change in inflammation inside the sinus cavities, as measured by the change in average of percentages of volume occupied by disease across the ethmoid and maxillary sinuses as measured by CT scan. Acute exacerbations of chronic rhinosinusitis was a pre-specified key outcome measure evaluated using pooled data from both ReOpen trials.
About Chronic Sinusitis
Chronic sinusitis (CS), cited as the second most common chronic disease of adults in the US2, is a serious chronic inflammatory disease affecting as many as 30 million adults in
XHANCE is a drug-device combination product that uses the Exhalation Delivery System (also referred to as the EDS) designed to deliver a topical anti-inflammatory to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by
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.
Please see full Prescribing Information.
- Smith SS, Evans CT, Tan BK, Chandra RK, Smith SB, Kern RC. National burden of antibiotic use for adult rhinosinusitis. J Allergy Clin Immunol. 2013 Nov;132(5):1230-2. doi: 10.1016/j.jaci.2013.07.009. Epub 2013 Aug 26. PMID: 23987794; PMCID: PMC3815964.
- Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol. 2011 Oct;128(4):693-707; quiz 708-9. doi: 10.1016/j.jaci.2011.08.004. Epub 2011
Sep 3. PMID: 21890184.
- Palmer JN, Messina JC, Biletch R, Grosel K, Mahmoud RA. A cross-sectional, population-based survey of
U.S.adults with symptoms of chronic rhinosinusitis. Allergy Asthma Proc. 2019 Jan 14;40(1):48-56. doi: 10.2500/aap.2019.40.4182. PMID: 30582496.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
Optinose Investor/Media Contact
Source: Optinose, Inc.