FDA Approves Xhance, Optinose’s Treatment for Adults with Chronic Rhinosinusitis Without Nasal Polyps

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Optinose announced that the FDA has approved Xhance as the first medication for adults with chronic rhinosinusitis without nasal polyps. According to the company, the FDA based the approval on positive data from the ReOpen clinical trial, which evaluated Xhance in this patient population. The treatment utilizes Optinose’s exhalation delivery system (EDS) to deliver fluticasone propionate directly to the inflamed areas, according to a press release.¹

“People who don’t suffer from chronic sinusitis may not appreciate how burdensome the condition can be. More than 80% of patients with chronic sinusitis report frustration with symptom relief when using a standard-delivery nasal steroid sprays, and patients commonly use multiple unproven over the counter medications in an effort to find symptom relief.” said Ramy Mahmoud, MD, MPH, CEO, Optinose, in the press release. “Although chronic sinusitis is one of the most common diagnoses in outpatient physician visits, and surgery is available, there has never been a prescription medication approved by the FDA as safe and effective to treat the millions of patients without nasal polyps suffering from this debilitating disease. We are thrilled to now be able to offer new hope to these patients and believe Xhance has the potential to become part of the standard of care for the treatment of chronic sinusitis.”

In terms of safety, trial results for Xhance were consistent with its currently labeled safety profile for the most part, with the most common adverse reactions being epistaxis, headache, and nasopharyngitis.¹

Back in 2017, Xhance was also approved by the FDA as a nasal spray treatment for nasal polyps. This approval was based on positive results from the Phase III NAVIGATE 1 and NAVIGATE 2 studies, testing efficiency against an EDS with placebo in adults with nasal polyposis and moderate-to-severe nasal congestion/obstruction. Results of these trials found that 90.6% of patients reported previous use of topical steroids, while 53.6% underwent a previous sinus surgery or polypectomy. After 16 weeks, both studies found that the Xhance 186 and 372 mcg treatment groups experienced greatly reduced congestion/obstruction at week four and total polyp grade at week 16.²

"Many patients are not satisfied with currently available treatment options, primarily due to inadequate symptom relief. We believe Xhance has the potential to improve the lives of millions of patients who are searching for new treatment options," said Peter Miller, CEO, Optinose, in a press release. "The approval of Xhance is a significant milestone on our journey towards creating a leading ENT/Allergy company."

According to the CDC, close to 28.9 million people in the United States have been diagnosed with chronic sinusitis.³

Common symptoms of the disease include, but aren’t limited to, nasal obstruction, blockage, congestion, discharge, chronic coughing, headaches, fever, and increased asthma symptoms.⁴

“The FDA approval of Xhance for the treatment of CRS without nasal polyps is an important milestone,” Rick Chandra, MD, 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, said in the press release. “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.”

References

1. XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps. Optinose. March 15, 2024. Accessed March 18, 2024. https://ir.optinose.com/news-releases/news-release-details/xhance-approved-fda-first-and-only-medication-indicated

2. Optinose Announces FDA approval of XHANCE™ (fluticasone propionate) nasal spray for the treatment of nasal polyps. Optinose. September 18, 2017. Accessed March 18, 2024. https://ir.optinose.com/news-releases/news-release-details/optinose-announces-fda-approval-xhancetm-fluticasone-propionate

3. Chronic Sinusitis. CDC. Accessed March 18, 2024. https://www.cdc.gov/nchs/fastats/sinuses.htm

4. Chronic Sinusitis. MedScape. January 19, 2022. Accessed March 18, 2024. https://emedicine.medscape.com/article/232791-overview