Optinose has gained approval from the US Food and Drug Administration (FDA) for Xhance (fluticasone propionate) nasal spray for chronic rhinosinusitis without nasal polyps in individuals, aged 18 or older.
Xhance is a drug-device combination product that utilises the Exhalation Delivery System (EDS) engineered to administer a topical steroid to the intricate and deep regions of the nasal cavity crucial for sinus ventilation and drainage.
By integrating a well-established nasal steroid with the Exhalation Delivery System, Xhance is intended to effectively target areas of inflammation. These include the challenging-to-access sinuses and sinonasal drainage pathways that are typically beyond the reach of conventional nasal sprays, said Optinose.
Optinose CEO Ramy Mahmoud said: “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.
“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.”
Xhance’s approval by the FDA was grounded on findings from the ReOpen programme, which assessed its efficacy in treating adults with chronic sinusitis.
The ReOpen programme encompassed two global Phase 3 trials, ReOpen1 and ReOpen2. Both the randomised, double-blind, placebo-controlled studies evaluated the effects of one or two sprays of Xhance in each nostril twice daily over 24 weeks in chronic sinusitis patients.
ReOpen1 involved 332 patients with or without concurrent nasal polyps, while ReOpen2 included 222 patients without polyps in the nasal cavity.
Primary endpoints included changes in symptom severity measured by composite symptom scores at week 4 and changes in sinus cavity inflammation assessed by CT scans at week 24.
Xhance demonstrated a safety profile consistent with its current labelling, with the most frequently reported adverse reactions in the ReOpen programme being epistaxis, headache, and nasopharyngitis, each occurring in at least 3% of patients.
