OptiNose said today that the FDA approved its Xhance nasal spray for the treatment of nasal polyps in patients 18 years and older.
The fluticasone propionate nasal spray is designed to deliver medication using OptiNose’s exhalation delivery system. The patient actuates the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device.
The Xhance product was tested in five clinical trials, including two Phase III pivotal trials in adults with nasal polyps and two Phase III trials in adults with chronic sinusitis.
Following treatment with the drug-device product, patients had statistically significant reductions of nasal congestion and obstruction after four weeks and total polyp grade after 16 weeks.
“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,” CEO Peter Miller said in prepared remarks. “The approval of Xhance is a significant milestone on our journey towards creating a leading ENT/allergy company.”
“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,” president Dr. Ramy Mahmoud added. “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.”