FDA OKs fluticasone propionate nasal spray for chronic rhinosinusitis without nasal polyps
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Key takeaways:
- The Exhalation Delivery System reaches inflamed areas of the nasal cavity and sinuses that other sprays miss.
- This is the first drug approved for chronic rhinosinusitis without nasal polyps.
The FDA has approved fluticasone propionate nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients aged 18 years and older, according to an Optinose press release.
Although current treatments including fluticasone propionate address nasal polyps, this is the first drug approved by the FDA to treat the more than two-thirds of patients with chronic rhinosinusitis who do not have nasal polyps.
“Until today, we had been forced to use unproven therapies to try and alleviate the symptoms that these patients suffer,” Rick Chandra, MD, professor of otolaryngology, head and neck surgery, Vanderbilt University, said in the press release.
“While we often result to using nasal steroid sprays in this patient population, they have never been shown to be effective in large placebo-controlled clinical studies,” Chandra continued.
Optinose’s fluticasone propionate nasal spray (Xhance) uses the Exhalation Delivery System to deliver fluticasone propionate to the areas of the nasal cavity and sinuses that are known to be extensively inflamed, Chandra said. Other nasal sprays typically fail to reach these areas.
This approval followed results from the phase 3 ReOpen clinical trials, which examined the efficacy and safety of one or two sprays in each nostril twice a day for 24 weeks among patients with chronic sinusitis.
ReOpen1 included 332 patients with chronic sinusitis with or without nasal polyps. ReOpen2 included 222 patients with chronic sinusitis without nasal polyps.
Patients who used Xhance experienced statistically significant improvements in composite symptom scores including congestion, facial pain or pressure, nasal discharge and sinus opacification compared with patients who used a comparator.
Treatment groups also experienced 56% to 66% reductions in frequency of acute exacerbations compared with placebo groups, in addition to reduced antibiotic usage and improved quality of life.
Additionally, the safety profile and tolerability were consistent with the drug’s currently labeled safety profile for other applications. With incidence rates of 3% or higher, the most common adverse reactions including epistaxis, headache and nasopharyngitis.