Optinose announces publication of results of Phase 3 EXHANCE-3 trial
Optinose announced that results of the Phase 3 EXHANCE-3 trial were published in the peer-reviewed journal Rhinology1, the official journal of the International Rhinologic Society. EXHANCE-3 was part of a comprehensive development program including five clinical trials evaluating XHANCE nasal spray in over 1,500 adult patients; including two randomized, double blinded, placebo controlled Phase 3 pivotal clinical trials in adults with nasal polyposis and two supportive open label Phase 3 clinical trials in adults with symptoms of chronic sinusitis with or without nasal polyps. Based upon the results of this program, the U.S. Food & Drug Administration approved XHANCE for the treatment of nasal polyps in patients 18 years of age and older in September 2017. EXHANCE-3 was a prospective, multicenter, 12-week, single-arm study evaluating the safety and efficacy of XHANCE 372 mcg twice daily in chronic sinusitis patients with or without nasal polyps. Eligible patients were 18 years of age or older and met diagnostic symptom criteria for CRS. In this study, 705 subjects were enrolled with 92.3% of patients reporting having previously tried corticosteroids and 27.5% reporting prior sinus surgery. All patients received XHANCE 372 mcg twice daily. The majority of spontaneously reported AEs were local in nature, mild in severity, and resolved spontaneously with continued use of XHANCE. The most common AEs included nasal mucosal disorder, spontaneously reported epistaxis, nervous system disorder, and nasal septum disorder. Important efficacy measures in EXHANCE-3 included: Sinonasal Outcome Test-22: At month 1, mean SNOT-22 total scores improved from baseline, with similar improvement in participants with nasal polyps or without nasal polyps of approximately 20 and 21 points, or 46% and 48% respectively. SNOT-22 scores improved more with longer duration of treatment through Month 3. Complete Response Analysis: After 3 months of treatment with XHANCE, approximately 48% of the patients who started the study with polyps were observed to have polyp elimination in at least one nostril. Patient Global Impression of Change: At month 3, 92% of patients with nasal polyps and 89% without nasal polyps reported improvement and 74% with nasal polyps and 68% without nasal polyps reported being ''much'' or ''very much'' improved. Other efficacy measures indicating improvement in this study included Lund-Kennedy endoscopic scoring of observed nasal pathology, indicators of potential need for surgery, and others.