Experts Issue New Treatment Algorithm for Chronic Rhinosinusitis with Nasal Polyps That Highlights Role of XHANCE® In Stepwise Care | Clinical Trials Medical Discoveries – About Your Online Magazine


YARDLEY, Pa., June 2, 2021 /PRNewswire/ – Optinose (NASDAQ: OPTN), a global specialty pharmaceutical company focused on meeting the needs of patients served by allergy and ear, nose, and throat (ENT) specialists, today announced the publication of a new escalated treatment algorithm of treatment in the International Allergy and Rhinology Forum, “Multidisciplinary consensus on a stepwise treatment algorithm for the management of chronic rhinosinusitis with nasal polyps, “recommends Exhalation Delivery System-fluticasone (EDS-FLU) for the treatment of patients with nasal polyps. It also recommends EDS-FLU as a step between initial care with standard intranasal steroids and before escalation of care with surgery or biological drugs.

The algorithm was informed by evidence-based, peer-reviewed data supporting the use of therapeutic and interventional treatments to arrive at the recommended graded care paradigm. The growing number of medical and surgical treatment options available to patients with nasal polyps can cause confusion among providers as to the optimal sequencing of these treatment modalities. The algorithm seeks to order the treatment and serve as a basis for improving the quality of care. The publication discusses considerations in a path to care that incorporates several new treatments approved in recent years in a logical gradual escalation of medical care, including but not limited to standard nasal steroid sprays, EDS-FLU, surgery, implants, and biologics .

“Over 85% of patients suffering from chronic rhinosinusitis with nasal polyps are frustrated by the lack of symptom relief they get with conventional nasal steroids,” he said.1 said Ramy Mahmoud, M.D., MPH, president of Optinose. “This is not surprising, since inflammation high and deep in the nasal cavity is at the root of the disease and can be difficult to achieve with standard nasal steroid sprays that patients typically try first.”2,3

XHANCE was approved by the US Food and Drug Administration in 2017 for the treatment of nasal polyps in patients 18 years of age and older and is the only drug available that uses EDS to deliver a high and deep anti-inflammatory drug to the source of the problem.

“Our goal is to share an emerging logical guideline of scaled care similar to that used in other disease areas, such as asthma, in which treatment is scaled up in stages in an attempt to achieve a complete response,” said Dr. Joseph Han, Head of the Division of Rhinology – Endoscopic Sinus and Skull Base Surgery and Head of the Division of Allergy at Eastern Virginia Medical School and first author of the consensus paper. “Medical staggered care guidelines can serve as a foundation to reduce confusion and improve quality of care. We hope that physicians, as well as payers, will find this new approach useful in guiding individual patient-based decision-making.”

In addition to Dr. Han, current president of the American Rhinologic Society, the expert panel that developed the consensus document is composed of otolaryngologists Christine Franzese, M.D., Kent Lam, M.D., Andrew P. Lane, M.D., Stella Lee, M.D., James Palmer, M.D., Zachary Soler, M.D. and Jivianne Lee, M.D. and allergists John V. Bosso, M.D., Seong H. Cho, M.D., and Anju Peters, M.D.

About nasal polyps

Nasal polyps are soft, non-cancerous (or benign) protrusions high up on the lining of the nasal passages or sinuses. Nasal polyps usually develop as part of the inflammatory process of chronic rhinosinusitis (CSR) and may worsen the inflammatory blockage of normal ventilation and sinus drainage. CRS is a chronic nasal inflammatory disease that can affect up to 30 million adults in the United States.4 The possibility of nasal polyps should be considered in patients with symptoms of chronic rhinosinusitis who respond poorly to traditional intranasal steroid sprays. An estimated 10 million patients suffer from nasal polyp symptoms in the US alone, leading to approximately $5.7 billion in direct costs annually.5

Treatments for nasal polyps include, but are not limited to, standard intranasal topical steroid sprays, XHANCE, short dose oral steroids, surgery, implants and biologicals.

About Optinosis

Optinose is a global specialty pharmaceutical company focused on meeting the needs of patients served by otolaryngologists and allergy specialists. To learn more, visit www.optinose.com or follow us on Twitter and LinkedIn.

About XHANCE®

XHANCE uses an Optinosis Exhalation Delivery System (EDS™) designed to deliver a topically acting anti-inflammatory corticosteroid to the high and deep regions of the nasal cavity, where nasal polyps originate. XHANCE was approved for the treatment of nasal polyps in patients 18 years of age and older by the US Food and Drug Administration in September 2017.

Important Safety Information

CONTRAINDICATIONS: Hypersensitivity to any XHANCE ingredient.

WARNINGS AND PRECAUTIONS:

  • Local nasal effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection and poor wound healing. Periodically monitor patients for signs of possible changes in the nasal mucosa. Avoid use on patients with recent nasal ulcers, nasal surgery, or nasal trauma.
  • Strict monitoring of glaucoma and cataract is guaranteed.
  • 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: Potentially increased susceptibility to or worsening of infections (eg, existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with care in patients with these infections. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • Hypercorticism and adrenal suppression can occur at very high dosages or with regular dosage in susceptible individuals. If these changes occur, stop 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 septum ulceration, nasopharyngitis, nasal mucosa erythema, nasal mucosa ulceration, nasal congestion, acute sinusitis, nasal septum erythema, headache and pharyngitis.

DRUG INTERACTIONS: Strong inhibitors of cytochrome P450 3A4 (eg, ritonavir, ketoconazole): use not recommended. May increase the risk of systemic corticosteroid effects.

USE IN SPECIFIC POPULATIONS: Liver failure. Monitor patients for signs of increased drug exposure.

Please see in full Prescription Information.

Media Contact:

Jonathan Neely

(267) 521-0531

Jonathan.Neely@optinose.com

Melissa Katz

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Mkatz@stonyhillcomms.com

1 Palmer et al. Allergy and Asthma Proc. 2019; 40 (1): 48-56.

two Sindwani,R., Han,J.K., Soteres,D.F., Messina, J.C., Carothers, J.L., Mahmoud, R.A., & Djupesland, P.G. (2019). NAVIGATE I: Double-blind, randomized, placebo-controlled trial of the fluticasone delivery system for chronic rhinosinusitis with nasal polyps. American Journal of Rhinology and Allergy, 33 (1), 69–82. https://doi.org/10.1177/1945892418810281

3 Leopold, D.A., Elkayam, D., Messina, J.C., Kosik-Gonzalez, C., Djupesland, P.G., & Mahmoud, R.A. (2019). NAVIGATE II: Randomized double-blind trial of the fluticasone exhalation delivery system for nasal polyposis. The Journal of Allergy and Clinical Immunology, 143 (1), 126-134.e5. https://doi.org/10.1016/j.jaci.2018.06.010

4 Pearlman AN, Chandra RK, Chang D, et al. Relationships between severity of chronic rhinosinusitis and nasal polyposis, asthma and atopy. Am J Rhinol Allergy. 2009; 23(2): 145-148.

5 Bhattacharyya et al. Laryngoscope. 2019; 129(9): 1969-1975.

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