Lactation Safety Information
For intranasal use
For topical use
Development and Regulatory status
H1 18: Optinose intends to explore strategic collaboration opportunities in Europe and the rest of the world in order to maximize the commercial potential and the availability of XHANCE .
Apr 18: Launched in the US 
Sep 17: US FDA approved for the treatment of nasal polyps in adults. The company annouced plans to launch in the US in Q2 2018
Jan 17: US FDA accepted for review for the treatment of nasal polyposis .
Nov 16: OptiNose filed an NDA for based on the results of the pIII NAVIGATE 1, NAVIGATE 2, EXHANCE-3; EXHANCE-12 and a PI bioavailability study .
Trial or other data
Oct 15: International NAVIGATE trial programme reported positive results from two double-blind RCT´s (N=323 pts per trial, including pts from the UK); NAVIGATE I (NCT01622569) and NAVIGATE II (EudraCT2011-004887-31, NCT01624662). Pts with bilateral nasal polyps were given intranasal fluticasone 100, 200 or 400µg, delivered by a bidirectional intranasal delivery device or placebo. In NAVIGATE I, intranasal fluticasone propionate resulted in significant reductions in nasal congestion or obstruction symptoms (P<0.001) as rated by patients and in total polyp grade (P<0.001) measured endoscopically. Fluticasone treated pts showed significant improvements in core disease symptoms such as nasal drainage, pain and pressure and loss of smell. In NAVIGATE II treatment with intranasal fluticasone led to reduction of nasal congestion/obstruction (-0.59, -0.68, and -0.62, respectively , P<0.001 vs placebo) and endoscopically measured total polyp grade (-1.31, -1.22, and -1.41, P < 0.001 vs placebo ). The most common adverse events were epistaxis and nasal mucosal disorder. [2-4]
Oct 15, Optinose completed 12 month, PIII EXHANCE-12 trial (N=223, NCT01623310) of 400μg intranasal fluticasone propionate given twice daily using a proprietary bi-directional device in pts with chronic sinusitis with or without polyps. Treatment with intranasal fluticasone propionate resulted in improvement in Sinonasal Outcomes Test (22-item) with mean improvement of 19.3 points, and on endoscopically assessed scores for change in local signs of disease, including nasal oedema. Most pts (72%) reported their symptoms being “much” or “very much” improved.[2-4]
Mar 15: Open-label, 3 month, PIII trial, EXHANCE-3 (N=706) completed in pts with chronic sinusitis with or without polyps (NCT01623323). Treatment with fluticasone propionate exhalation delivery system (FLU-EDS) showed complete resolution in 33.3% of pts with chronic rhinosinusitis with nasal polyps (CRSwNP) and 54.8% of pts with chronic rhinosinusitis without nasal polyps (CRSsNP). Improvement in Sino-Nasal Outcome Test - 22 scores were observed in CRSwNP (-23.7) and CRSsNP (-24.4). The most common adverse events were epistaxis and nasal mucosal disorder. [2-4]