XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
- Optinose receives FDA approval for XHANCE nasal spray to treat chronic rhinosinusitis without nasal polyps
- XHANCE demonstrated a statistically significant reduction in symptoms, sinus inflammation, and acute exacerbations in clinical trials
- XHANCE uses a proprietary Exhalation Delivery System to target areas of inflammation deep in the nose
- Chronic sinusitis affects approximately 30 million adults in the U.S.
- XHANCE has the potential to become part of the standard of care for the treatment of chronic sinusitis
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The FDA approval of XHANCE nasal spray for chronic rhinosinusitis without nasal polyps represents a significant advancement in the treatment landscape for a condition that affects a considerable segment of the adult population in the U.S. The clinical trial data showcasing a statistically significant reduction in symptoms and inflammation, as well as a decrease in acute exacerbations, is noteworthy. These exacerbations often lead to antibiotic prescriptions, which have implications for antibiotic resistance and healthcare costs. The introduction of XHANCE could potentially reduce the reliance on antibiotics and surgeries, which are currently prevalent in managing this chronic condition.
Furthermore, the proprietary Exhalation Delivery System utilized by XHANCE allows for targeted delivery of the steroid to inflamed areas within the nasal cavity, addressing a key limitation of standard nasal sprays. This targeted approach could improve patient outcomes and quality of life, which is particularly relevant given the chronic nature of sinusitis and its comparable impact on quality of life to conditions like COPD and migraines. The safety profile consistency with the currently labeled safety profile is also a positive aspect, minimizing concerns for new adverse effects.
Chronic sinusitis without nasal polyps constitutes a substantial burden on the healthcare system, accounting for millions of outpatient visits and a significant number of surgeries annually. The economic implications of XHANCE's FDA approval are multifaceted. On one hand, the drug-device combination could alleviate some of the direct medical costs associated with chronic sinusitis by reducing the need for surgeries and potentially curbing antibiotic usage. On the other hand, indirect costs related to lost productivity and quality of life could also see improvement.
However, the pricing strategy for XHANCE and its adoption by ENT specialists will play a important role in determining its economic impact. If priced competitively and covered by insurance plans, XHANCE could see widespread use, which might lead to overall cost savings for the healthcare system. Conversely, if the drug is priced at a premium without clear cost-benefit advantages over existing treatments, its impact could be limited. Long-term studies on healthcare resource utilization and patient-reported outcomes post-adoption will be instrumental in assessing the true economic impact of this new treatment option.
From a market perspective, Optinose's FDA approval for XHANCE could position the company to capture a significant share of the chronic sinusitis treatment market, especially since there is currently no approved medication for the majority of patients who do not have nasal polyps. The market potential is underscored by the estimated 30 million adults in the U.S. suffering from this condition. The company's stock performance and by extension investor interest, will likely be influenced by the commercial rollout of XHANCE, market adoption rates and the competitive response from other pharmaceutical companies with interests in the ENT space.
Investors will be monitoring prescription trends, insurance coverage decisions and real-world efficacy and safety data. Optinose's ability to effectively market XHANCE to both ENT specialists and primary care physicians will be critical, as will the company's supply chain and distribution capabilities. As XHANCE becomes integrated into standard care practices for chronic sinusitis, its long-term impact on Optinose's financial health and market valuation will become clearer.
ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps
Clinical trial program also showed reduction in sinus inflammation and in acute exacerbations, which frequently result in use of antibiotics
XHANCE uses the proprietary Exhalation Delivery System to enable deposition of a proven steroid in target areas of inflammation deep in the nose not typically reached by standard nasal sprays
Chronic sinusitis affects approximately 30 million adults in the U.S.
YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has approved XHANCE® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.
Chronic sinusitis (also called “chronic rhinosinusitis” or “CRS”) is one of the most common chronic diseases, affecting approximately 30 million adults in the United States. Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine. Chronic sinusitis is also one of the most common diagnoses in adult outpatient medicine. Chronic sinusitis is diagnosed in approximately 10 million outpatient visits, of which approximately
“The FDA approval of XHANCE for the treatment of CRS without nasal polyps is an important milestone,” said Rick Chandra, M.D., Professor of Otolaryngology-Head and Neck Surgery, Endowed Director, Roland “Ron” Eavey, MD, SM Endowed Directorship in Leadership and Education, Service Chief, Rhinology and Skull Base Surgery, Vanderbilt University. “Until today, we have been forced to use unproven therapies to try and alleviate the symptoms that these patients suffer. While we often resort to using nasal steroid sprays in this patient population, they have never been shown to be effective in large placebo-controlled clinical studies. XHANCE, which uses the Exhalation Delivery System to enable delivery of an established topical steroid to the areas of the nasal cavity and sinuses we know to be extensively inflamed, is now proven to be effective in treating our CRS patients both with and without nasal polyps.”
“People who don’t suffer from chronic sinusitis may not appreciate how burdensome the condition can be. More than
The approval was based on data from the ReOpen program evaluating XHANCE for treatment of adults with chronic sinusitis. A drug-device combination product, XHANCE uniquely combines a widely used nasal steroid with the Exhalation Delivery System™, an innovative delivery system designed to target the sites where inflammation occurs, especially difficult-to-access sinuses and sinonasal drainage tracts not typically reached by standard-delivery nasal sprays.
The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile. The most common adverse reactions (incidence ≥
About Optinose
Optinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on X and LinkedIn.
About XHANCE
XHANCE® is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for the treatment of chronic rhinosinusitis (with and without nasal polyps) in patients 18 years of age or older.
About the ReOpen Program
The ReOpen program comprised two global, randomized, double-blind, placebo-controlled Phase 3 trials that evaluated the efficacy and safety of one or two sprays of XHANCE in each nostril twice daily, over 24 weeks, in patients suffering from chronic sinusitis. In ReOpen1, the first of the two trials, 332 chronic sinusitis patients either with or without concurrent nasal polyps were treated. In ReOpen2, 222 chronic sinusitis patients who did not have polyps in the nasal cavity were treated. The co-primary endpoints were change from baseline in symptoms, as measured by composite symptom score (nasal congestion, facial pain or pressure, and nasal discharge) at the end of week 4, and change in inflammation inside the sinus cavities, as measured by CT scans (change in the average of the percentages of volume occupied by disease in the ethmoid and maxillary sinuses) at week 24. The ReOpen trial program is a landmark research program that included the first ever large, placebo-controlled trials we are aware of to demonstrate that any nasal medication produces significant improvement in both symptoms and inflammation inside the sinuses for patients with chronic sinusitis, regardless of whether or not nasal polyps are present, and to show reduction in the number of acute exacerbations.1
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. 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 until healing has occurred.
- Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.
- 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 and infections can occur, including 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.
- Assess for decrease in bone mineral density initially and periodically thereafter.
ADVERSE REACTIONS:
- Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥
3% ) are epistaxis, headache, and nasopharyngitis. - Chronic rhinosinusitis with nasal polyps: 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, including Instructions for Use
References
- James N. Palmer, Nithin D. Adappa, Rakesh K. Chandra, Greg E. Davis, Mahboobeh Mahdavinia, John Messina, Randall A. Ow, Zara M. Patel, Anju T. Peters, Harry Sacks, Rodney J. Schlosser, Raj Sindwani, Zachary M. Soler, Andrew A. White, Sarah K. Wise, Ramy A. Mahmoud, Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2), The Journal of Allergy and Clinical Immunology: In Practice, 2024,, ISSN 2213-2198, https://doi.org/10.1016/j.jaip.2023.12.016. (https://www.sciencedirect.com/science/article/pii/S221321982301365X)
Cautionary Note on 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 hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the benefits of XHANCE for the treatment of chronic sinusitis (also called chronic rhinosinusitis) with and without nasal polyps; the benefits of the approval of XHANCE for the treatment of chronic rhinosinusitis without nasal polyps; the potential for XHANCE to become part of the standard of care for the treatment of chronic sinusitis; the benefits of the Exhalation Delivery System; and other statements regarding the Company's future operations, prospects, objectives, and other future events. Forward-looking statements are based upon 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 by such forward-looking statements including, among others: physician and patient acceptance of XHANCE for its new indication (treatment of adults with chronic rhinosinusitis without nasal polyps); the Company’s ability to maintain adequate third party reimbursement for XHANCE (including its new indication); potential for varying interpretation of clinical trial results of XHANCE for the treatment of chronic sinusitis; ; the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than the Company expects; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in our most recent Form 10-K and Form 10-Q filings 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 statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and we undertake no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
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