The FDA has approved Optinose’s Xhance fluticasone propionate nasal spray (formerly OPN-375) for the treatment of nasal polyps, the company said. The product, which is based on the company’s exhalation delivery technology, should be available in the US by mid-2018.
In January 2017, OptiNose announced that the FDA had accepted its NDA for OPN-375. The company had announced positive results from pivotal studies of the nasal spray in 2015.
Optinose CEO Peter Miller commented, “Many patients are not satisfied with currently available treatment options, primarily due to inadequate symptom relief. We believe Xhance has the potential to improve the lives of millions of patients who are searching for new treatment options. The approval of Xhance is a significant milestone on our journey towards creating a leading ENT/allergy company.”
Optinose President Ramy Mahmoud added, “Our team has invested a great deal of energy in creating this product, and in all the research and development necessary to obtain FDA approval, because we are passionate about improving patient care. We would like to thank the investigators, and their teams, who participated in the Xhance clinical research program, and most especially thank the patients who agreed to take part. We very much look forward to making Xhance available for patients in the second quarter of 2018.”
Read the Optinose press release.
