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YARDLEY, Pa., Sept. 06, 2022 (GLOBE NEWSWIRE) — Optinose (NASDAQ:OPTN), a pharmaceutical firm targeted on sufferers handled by ear, nostril and throat (ENT) and allergy specialists, right this moment introduced that information from its ReOpen1 section 3 medical trial will likely be offered on the American Rhinologic Society (ARS) 68th Annual Meeting in Philadelphia, Pennsylvania on September 9, 2022.
ReOpen1 was the primary of two section 3 medical trials in its ReOpen Program which evaluated XHANCE, additionally known as the Exhalation Delivery System with fluticasone (EDS-FLU), as a possible therapy for continual sinusitis.
Podium Presentation: Re-Open-1: A randomized double-blind placebo-controlled trial of EDS-FLU for CRSwNP or CRSsNP, is scheduled for Friday, September 9, 2022 at 1:23 p.m. ET through the Top-Rated Abstracts – Clinical Rhinology session. James Palmer, MD, FARS will current.
This presentation is meant for scientific dialogue solely.
About the ReOpen Program
The ReOpen program includes two international, randomized, double-blind, placebo-controlled Phase 3 trials that evaluated the efficacy and security of 1 or two sprays of XHANCE (OPN-375) in every nostril twice each day, over 24 weeks, in sufferers affected by continual sinusitis (CS). In ReOpen1, the primary of the 2 trials, 332 sufferers have been handled who had CS with or with out nasal polyps. In ReOpen2, the second of the 2 trials, 222 sufferers have been handled who had CS with out nasal polyps. The co-primary endpoints have been change from baseline in signs, as measured by a composite rating of patient-reported signs (together with nasal congestion, facial ache or stress sensation, and nasal discharge) on the finish of week 4, and goal change in irritation contained in the sinus cavities, as measured by the change in common of percentages of quantity occupied by illness throughout the ethmoid and maxillary sinuses as measured by CT scan.
About Chronic Sinusitis
Chronic sinusitis (CS), cited because the second most typical continual illness of adults within the US1, is a critical continual inflammatory illness affecting as many as 30 million adults within the United States and costing the U.S. economy over $30 billion in direct and oblique prices yearly.2 CS is characterised by continual irritation affecting the paranasal sinuses and the nasal cavity, the place the openings from the sinuses usually ventilate and drain. Chronic sinusitis is related to signs that persist for at the least 12 weeks, with most sufferers struggling for a few years. In addition, the situation is commonly related to a number of acute exacerbations that end in substantial use of antibiotics. In some sufferers, continual sino-nasal irritation is accompanied by improvement of polyps within the nasal cavities, known as nasal polyposis. Today, there are not any FDA-approved drug therapies for the vast majority of continual sinusitis sufferers who should not have nasal polyps, although there are medicines, together with XHANCE, accepted by FDA for therapy of nasal polyps. The time period “chronic rhinosinusitis” can also be usually used as an umbrella time period in medical literature to consult with sufferers with continual inflammatory illness within the nostril and sinuses, with or with out nasal polyps.
About Optinose
Optinose is a specialty pharmaceutical firm targeted on serving the wants of sufferers cared for by ear, nostril and throat (ENT) and allergy specialists. To be taught extra, please go to www.optinose.com or comply with us on Twitter and LinkedIn.
About XHANCE
XHANCE is a drug-device mixture product that makes use of the Exhalation Delivery System (additionally known as the EDS) designed to ship a topical anti-inflammatory to the excessive and deep areas of the nasal cavity the place sinuses ventilate and drain. XHANCE is accepted by U.S. Food and Drug Administration for the therapy of nasal polyps in sufferers 18 years of age or older and has been studied for therapy of continual sinusitis in two section 3 trials, ReOpen1 and ReOpen2. Top-line outcomes from these trials are the primary ever that we’re conscious of that present enchancment in each signs and irritation contained in the sinuses and discount in acute exacerbations of illness with a nasal remedy for continual sinusitis sufferers, together with these with and with out nasal polyps. If accepted, XHANCE would be the first drug ever FDA-approved for therapy of continual sinusitis both with or with out 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 an infection, and impaired wound therapeutic. Monitor sufferers periodically for indicators of doable modifications on the nasal mucosa. Avoid use in sufferers with current nasal ulcerations, nasal surgical procedure, 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 happen.
- Immunosuppression: potential elevated susceptibility to or worsening of infections (e.g., current tuberculosis; fungal, bacterial, viral, or parasitic an infection; ocular herpes simplex). Use with warning in sufferers with these infections. More critical and even deadly course of chickenpox or measles can happen in inclined sufferers.
- Hypercorticism and adrenal suppression could happen with very excessive dosages or on the common dosage in inclined people. If such modifications happen, discontinue XHANCE slowly.
- Patients with main threat elements for decreased bone mineral content material must be monitored and handled with established requirements of care.
ADVERSE REACTIONS: The most typical adversarial 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 advisable. May enhance threat of systemic corticosteroid results.
USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor sufferers for indicators of elevated drug publicity.
Please see full Prescribing Information.
References
- Hamilos DL. Chronic rhinosinusitis: epidemiology and medical administration. 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 Okay, Mahmoud RA. A cross-sectional, population-based survey of U.S. adults with signs of continual 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 launch comprises forward-looking statements throughout the that means of the U.S. Private Securities Litigation Reform Act of 1995. All statements that aren’t historic details are hereby recognized as forward-looking statements for this function and embrace, amongst others, statements regarding the date, time and particulars of the presentation at ARS; the potential advantages of XHANCE for treating continual sinusitis and decreasing illness exacerbations; the Company’s plans to hunt approval for a follow-on indication for XHANCE for the therapy of continual sinusitis and the potential advantages of such indication; the potential for XHANCE to be the primary FDA-approved drug product for the therapy of continual sinusitis; and different statements concerning the Company’s future operations, monetary efficiency, monetary place, prospects, aims and different future occasions. Forward-looking statements are primarily based upon administration’s present expectations and assumptions and are topic to quite a lot of dangers, uncertainties and different elements that might trigger precise outcomes and occasions to vary materially and adversely from these indicated by such forward-looking statements together with, amongst others: potential for various interpretation of the outcomes from the ReOpen Trial program; uncertainties associated to the medical improvement program and regulatory approval of XHANCE for the therapy of continual sinusitis; and the dangers, uncertainties and different elements mentioned below the caption “Item 1A. Risk Factors” and elsewhere within the Company’s most up-to-date Form 10-Okay and Form 10-Q filings with the Securities and Exchange Commission – which can be found at www.sec.gov. As a end result, you’re cautioned to not place undue reliance on any forward-looking statements. Any forward-looking statements made on this press launch converse solely as of the date of this press launch, and the Company undertakes no obligation to replace such forward-looking statements, whether or not because of new data, future developments or in any other case.
Optinose Investor/Media Contact
Jonathan Neely
[email protected]
267.521.0531
