The FDA has accepted OptiNose’s new drug application for its OPN-375 intranasal fluticasone for the treatment of nasal polyposis in adult patients, with an anticipated PDUFA date in September 2017, the company announced.
OptiNose CEO Peter Miller commented, “The FDA acceptance of the new drug application for OPN-375 is a particularly exciting milestone for our company because OPN-375 represents the first step on our path towards becoming a leading ENT/Allergy specialty company. The 2016 FDA approval of the first product we developed using our proprietary Exhalation Delivery System (EDS) technology gives us more confidence that our second EDS product, OPN-375, can be approved in 2017.”
President and COO Ramy Mahmoud added, “We believe there is a great deal of dissatisfaction with the current clinical options for these patients, and that OPN-375 could be a valuable new treatment option. Our team is eager for the opportunity to make this new product available to patients if it is approved, and we are already taking the necessary steps to make it happen.”
In September 2015, the company announced positive results from pivotal studies of OPN-375. The next month, OptiNose announced that it had raised $30 million to complete development of OPN-375 and to commercialize the product if approved.
Read the OptiNose press release.
