Yardley, Pennsylvania, June 2, 2021 / PRNewswire / –Optinolaryngology (ENT) and Optinose (NASDAQ: OPTN), a global specialty pharmaceutical company that addresses the needs of allergy specialists, today announced the announcement of a new step-by-step treatment. did.Treatment algorithm International Forum on Allergy and Nasal Science, “Interdisciplinary agreement on a step-by-step treatment algorithm for the management of chronic sinusitis with nasal polyps, “Recommends a breath delivery system-fluticasone (EDS-FLU) for the treatment of patients with nasal polyps, as well as initial care with standard intranasal steroids and pre-escalation steps of surgical or biologic care EDS-FLU is recommended as.
This algorithm was communicated by evidence-based peer-reviewed data supporting the use of therapeutic and interventional treatments to reach the recommended step-by-step care paradigm. Increasing medical and surgical treatment options available to patients with nasal polyps can lead to confusion among healthcare providers regarding the optimal order of these treatments. This algorithm aims to serve as the basis for ordering treatment and improving the quality of care. This publication presents several new therapies approved in recent years, including but not limited to standard nasal steroid sprays, EDS-FLU, surgery, implants, and biologics, a logical step-by-step escalation of medical care. Describes considerations in the care pathways that are incorporated into.
“More than 85% of patients suffering from chronic sinusitis with nasal polyps are dissatisfied with the fact that standard nasal steroids do not relieve their symptoms.”1 Said Rummy Mahmood, MD, MPH, President of Optinose. “This is not surprising, because inflammation in the nasal cavity underlies the disease and can be difficult to reach with the standard nasal steroid sprays that patients usually try first.”2,3
XHANCE was approved by the US Food and Drug Administration in 2017 for the treatment of nasal polyps in patients over the age of 18, and is the only drug that uses EDS to deliver anti-inflammatory drugs deep into the affected area. problem.
“Our goal is to share new logical step-by-step treatment guidance similar to that used in other disease areas such as asthma, where treatment is escalated in stages to achieve a complete response. Is to do. ” Joseph Han, Nasal–Chief of Endoscopic Sinsal and Skull Base Surgery, Chief of Allergology at Eastern Virginia Medical College, and Lead Author of Consensus Treatises. “Step-by-step care guidelines in health care serve as the basis for reducing confusion and improving the quality of care. Physicians as well as payers, this new approach guides individual patient-based decision making. I hope it helps. “
In addition to Dr. Han, the current president of the American Society of Nasal Sciences, the expert committee that produced the consensus treatise consists of otolaryngologists. Christine Francese, MD, Kent Lamb, MD, Andrew P. Lane, MD, Stella Lee, MD, James Palmer, MD, Zackery Sorrel, MD, and Givianne Lee, MD, and Allergists John V. Bosso, MD, Song Ho Cho, MD, and Anju Peters, MD
About nasal polyps
Nasal polyps are soft, non-cancerous (or benign) protrusions at the medial height of the nasal or sinuses. Nasal polyps usually occur as part of the inflammatory process of chronic sinusitis (CRS) and can exacerbate the inflammatory obstruction of normal ventilation and drainage from the sinuses. CRS is a chronic nasal inflammatory disease that can affect as many as 30 million adults. USA..Four The possibility of nasal polyps should be considered in patients with symptoms of chronic sinusitis who are inadequately responding to conventional intranasal steroid sprays. In the United States alone, 10 million patients suffer from nasal polyp symptoms and are estimated to cost approximately $ 5.7 billion annually.Five
Treatment of nasal polyps includes, among other things, standard intranasal steroid topical sprays, XHANCE, short bursts of oral steroids, surgery, implants, and biologics.
Optinose is a global specialty pharmaceutical company focused on meeting the needs of patients under the care of otolaryngologists (ENT) and allergists. Learn more about. www.optinose.com Or follow us twitter And LinkedIn..
XHANCE uses the Optinose Exhalation Delivery System (EDS ™), which is designed to deliver locally acting anti-inflammatory corticosteroids to the high and deep areas of the nasal cavity where nasal polyps occur. XHANCE was approved by the US Food and Drug Administration in September 2017 for the treatment of nasal polyps in patients age 18 and older.
Important safety information
Contraindications: Hypersensitivity to the ingredients of XHANCE.
Warnings and notes:
- Local nasal effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Patients are regularly monitored for signs of change in the nasal mucosa. Do not use for patients with recent nasal ulcers, nasal surgery, or nasal trauma.
- Close monitoring of glaucoma and cataracts is required.
- Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. If you experience this reaction, discontinue use of XHANCE.
- Immunosuppression: Potential increase or exacerbation of susceptibility to infections (eg, existing tuberculosis, fungi, bacteria, viruses, or parasitic infections, herpes simplex). Use with caution in patients with these infections. A more serious or fatal course of chickenpox or measles can occur in sensitive patients.
- Hypercortical hyperfunction and adrenal suppression can occur at very high doses or at normal doses in sensitive individuals. If you experience any of these changes, stop XHANCE slowly.
- Patients with a major risk factor for decreased bone mineral content should be treated with monitored and established standard treatment.
Adverse reactions: The most common side effects (incidence> 3%) are epistaxis, septal ulcer, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcer, nasal congestion, acute sinusitis, nasal septal erythema, headache, sore throat.
Drug interaction: Strong cytochrome P450 3A4 inhibitors (eg ritonavir, ketoconazole): Not recommended for use. May increase the risk of systemic corticosteroid effects.
Use in certain populations: Liver disorder. Monitor signs of increased drug exposure in patients.
Please see all Prescription information..
1 Palmer et al. Allergy and Asthma Proc. 2019; 40 (1): 48-56.
2 Sindwani, R., Han, JK, Sotelis, DF, Messina, JC, Carothers, JL, Mahmoud, RA, and Djupesland, PG (2019). Navigate I: A randomized, placebo-controlled, double-blind study of the fluticasone breath delivery system for chronic sinusitis with nasal polyps. Journal of American Nose and Allergies, 33 (1), 69-82. https://doi.org/10.1177/1945892418810281
3 Leopold, DA, El Kayam, D., Messina, JC, Kosik-Gonzalez, C., Djupesland, PG, and Mahmoud, RA (2019). NAVIGATE II: A randomized, double-blind study of a fluticasone breath delivery system for nasal polyps. Journal of Allergies and Clinical Immunology, 143 (1), 126–134.e5. https://doi.org/10.1016/j.jaci.2018.06.010
Four Perlman AN, Chandra RK, Chan D, etc. Relationship between the severity of chronic sinusitis and nasal polyps, asthma, and atopy. Am J Rhinol I’m allergic. 2009; 23 (2): 145-148.
Five Bhattacharyya etc. Laryngoscope. 2019; 129 (9): 1969-1975.
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Experts Announce New Treatment Algorithm for Chronic Sinusitis with Nasal Polyps, Emphasizing the Role of XHANCE® in Phased Care | Around the Web-Pennsylvania
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