OptiNose has announced positive results from the NAVIGATE I Phase 3 trial of its OPN-375 intranasal fluticasone for the treatment of nasal polyposis demonstrating statistically significant reduction of symptoms and total polyp grade. In June 2015, the company announced positive results from the NAVIGATE II trial. Based on the results from both studies, OptiNose said, the company will begin preparing an NDA for submission to the FDA.
The 24-week NAVIGATE I randomized, double-blind, placebo-controlled trial enrolled 323 patients from 6 countries. Two thirds of patients receiving OPN-375 reported that symptoms were “much” or “very much” improved at 16 weeks post treatment, and approximately 29% of patients treated with the highest dose experienced complete elimination of polyps 6 months after treatment.
OptiNose CEO Peter Miller said, “We believe these results provide validation of the promise of OPN-375 in treating nasal polyps and its potential to be an important new tool in the treatment arsenal for this condition. The positive results further strengthen the growing body of evidence from our ongoing clinical development program for OPN-375 as a potential treatment for chronic rhinosinusitis with or without nasal polyps. . . . Today’s announcement represents an important milestone for OptiNose as a company, but more importantly we are excited at the prospect of helping to address an area with such significant unmet need.”
Read the OptiNose press release.
