Optinose announced that the Food and Drug Administration (FDA) has approved Xhance (fluticasone propionate) Nasal Spray for the treatment of nasal polyps in patients aged ≥18 years.
Xhance utilizes the Exhalation Delivery System (EDS) that delivers the medicine to deep areas in the nose. Xhance is delivered by actuating the pump spray into one nostril while blowing into the mouthpiece of the device at the same time. Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Corticosteroids exert a range of effects on multiple cell types and mediators involved in inflammation.
Xhance was evaluated in five trials enrolling >1,500 adults, including the Phase 3 NAVIGATE 1, NAVIGATE 2, XHANCE-12, and XHANCE-3 trials. NAVIGATE 1 and NAVIGATE 2 were randomized, double-blinded, placebo-controlled trials in adults with nasal polyps comparing Xhance and an EDS with placebo. XHANCE-12 and XHANCE-3 were open-label trials in adults with chronic sinusitis with and without nasal polyps.
Prior to study initiation, most patients in NAVIGATE 1 and NAVIGATE 2 had been treated with intranasal steroids (90.6%) and/or had sinus surgery or polypectomy (53.6%). Study patients were randomized to Xhance 186mcg and 372mcg twice daily or an EDS with placebo. After treatment with Xhance, both the 186mcg and 372mcg treatment groups showed statistically significant reductions in nasal congestion/obstruction at Week 4 and total polyp grade at Week 16.
Xhance will be available as a 93mcg strength intranasal spray containing 120 metered sprays. It is anticipated to launch in the second quarter of 2018.
For more information call (800) 721-5072 or visit Xhance.com.