YARDLEY, Pa., Nov. 9, 2022 (GLOBE NEWSWIRE) — Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by otolaryngologists (ENTs) and allergy specialists, today announced that data from its Phase 3 ReOpen2 clinical trial will be presented at the American College of Asthma, Allergy, and Allergy Scientific Meeting. Annual of Immunology (ACAAI) 2022 in Louisville, Kentucky on November 12, 2022.
ReOpen2 was the second of two Phase 3 clinical trials in its ReOpen Program that evaluated XHANCE, also known as Fluticasone Exhalation Delivery System (EDS-FLU), as a potential treatment for chronic sinusitis.
Electronic Poster Presentation (P217): Randomized controlled trial of fluticasone exhalation delivery system for chronic rhinosinusitis without nasal polyps, is scheduled for Saturday, November 12, 2022 at 12:05 pm ET during a Rhinitis and Other Upper Respiratory Disorders session on Monitor 14.
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 applications of XHANCE (OPN-375) in each nostril twice daily for 24 weeks. in patients suffering from chronic sinusitis (CS). In ReOpen1, the first of two trials, 332 patients who had CS with or without concurrent nasal polyps were treated. In ReOpen2, the second of two trials, 222 patients who had CS were treated, none of whom also had nasal polyps. 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, and nasal discharge) through week 4, and change in inflammation within the sinus cavities. , measured by the change in the average percentages of volume occupied by the disease through the ethmoid and maxillary sinuses measured by computed tomography.
About chronic sinusitis
Chronic sinusitis (CS), cited as the second most common chronic disease of adults in the US1is a serious chronic inflammatory disease that affects an estimated 30 million adults in the United States and costs the US economy more than $30 billion in direct and indirect costs each year.two CS is characterized by chronic inflammation that affects the sinuses and nasal cavity, where the sinus openings normally ventilate and drain. Chronic sinusitis is associated with symptoms that persist for at least 12 weeks, with most patients suffering for many years. Additionally, the condition is often associated with multiple acute exacerbations resulting in substantial antibiotic use. In some patients, chronic sinus inflammation is accompanied by the development of polyps in the nasal cavities, which is known as nasal polyposis. Currently, there are no FDA-approved drug treatments for most patients with chronic sinusitis who do not have nasal polyps, although there are medications, including XHANCE, that are FDA-approved for the treatment of nasal polyps. The term “chronic rhinosinusitis” is also often used as a generic term in the medical literature to refer to patients with chronic inflammatory disease of the nose and sinuses, with or without nasal polyps.
Optinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose, and throat (ENT) and allergy specialists. For more information, visit optinose.com or follow us on Twitter Y LinkedIn.
XHANCE is a combination drug and device product utilizing the exhalation delivery system (also known as EDS) designed to deliver a topical anti-inflammatory to the upper and deeper regions of the nasal cavity where the sinuses ventilate and drain. XHANCE is approved by the US Food and Drug Administration for the treatment of nasal polyps in patients 18 years of age and older and has been studied for the treatment of chronic sinusitis in two Phase 3 trials, ReOpen1 and ReOpen2. The top-line results from these trials are the first to our knowledge showing an improvement in both symptoms and inflammation within the sinuses, and a reduction in acute exacerbations of the disease, with a nasal therapy for patients with sinusitis. chronic, including patients with or without nasal polyps. If approved, XHANCE may be the first drug approved by the FDA for the treatment of chronic sinusitis with or without nasal polyps.
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 in the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma.
- Close surveillance for glaucoma and cataracts is warranted.
- Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported following administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
- Immunosuppression: Potential for increased susceptibility to or worsening of infections (eg, existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. A more serious or even fatal course of chicken pox or measles can occur in susceptible patients.
- Hypercorticism and adrenal suppression can occur at very high doses or at the regular dose in susceptible individuals. If such changes occur, slowly discontinue XHANCE.
- Patients with significant 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 (eg, ritonavir, ketoconazole): Use is not recommended. May increase the risk of systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS: liver impairment Monitor patients for signs of increased drug exposure.
please see complete prescription information.
- Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol. 2011 October; 128 (4): 693-707; test 708-9. doi: 10.1016/j.jaci.2011.08.004. Epub 2011 September 3. PMID: 21890184.
- Palmer JN, Messina JC, Biletch R, Grosel K, Mahmoud RA. A population-based cross-sectional survey of US adults with symptoms of chronic rhinosinusitis. Allergy Asthma Proc. 2019 January 14; 40(1):48-56. doi: 10.2500/aap.2019.40.4182. PMID: 30582496.
Cautionary Note Regarding 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 identified as forward-looking statements for this purpose and include, but are not limited to other, statements related to the date, time and details of the presentation in ACAAI; the potential benefits of XHANCE in treating chronic sinusitis and reducing disease flares; the Company’s plans to seek approval of a follow-up indication for XHANCE for the treatment of chronic sinusitis and the potential benefits of such an indication; the potential of XHANCE to be the first pharmaceutical product approved by the FDA for the treatment of chronic sinusitis; and other statements regarding the future operations, financial performance, financial position, prospects, objectives and other future events of the Company. Forward-looking statements are based on management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated in such forward-looking statements. including, but not limited to: possibility of variable interpretation of the results of the ReOpen Trial program; uncertainties related to the clinical development program and regulatory approval of XHANCE for the treatment of chronic sinusitis; and the risks, uncertainties and other factors discussed under the heading “Item 1A. Risk Factors” and elsewhere in the Company’s most recent Form 10-K and Form 10-Q with the Securities and Exchange Commission, which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update any such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Investor/Media Contact