The FDA has approved fluticasone propionate nasal spray (Xhance, Optinose) for the treatment of nasal polyps in patients 18 years of age and older. It is estimated that up to 10 million Americans suffer from nasal polyps and the symptoms that accompany them.
“This is a serious disease that causes significant suffering due to inflammation. In fact, the decreased quality of life matches other serious diseases, such as congestive heart failure, chronic obstructive pulmonary disease, or coronary artery disease, in several studies,” James Palmer, MD, Professor and Director of the Division of Rhinology at the University of Pennsylvania in Philadelphia and President-Elect of the American Rhinologic Society, said in a press release. “The approval of Xhance is great news because it will give doctors and patients an effective new option that gets corticosteroid medication deep in the nose to treat the inflammation.”
Fluticasone propionate nasal spray, 93 mcg, for intranasal administration, is designed to deliver medicine to targeted areas deep in the nose by using a new approach called an exhalation delivery system. The drug is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device. The recommended adult dosage is one spray per nostril twice daily (for a total daily dose of 372 mcg). Two sprays per nostril twice daily may also be effective in some patients (a total daily dose of 744 mcg), according to the company.
The development program for the product included five clinical trials evaluating more than 1,500 adult patients, including two randomized, double-blinded, placebo-controlled phase 3 pivotal trials in adults with nasal polyps (NAVIGATE 1 and NAVIGATE 2) and two open-label phase 3 clinical trials in adults with chronic sinusitis with and without nasal polyps (XHANCE-12 and XHANCE-3). Most patients in both NAVIGATE trials had been treated previously with intranasal steroids and/or had sinus surgery or polypectomy. With fluticasone propionate nasal spray treatment, patients experienced statistically significant reductions of both nasal congestion/obstruction at week 4 and total polyp grade at week 16, which were the coprimary endpoints.
The most commonly reported adverse events greater than or equal to 3% and greater than placebo in the NAVIGATE trials were epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. Five percent of patients treated with 186 mcg twice daily and 1.2% of patients treated with 372 mcg twice daily dropped out of the clinical trials during the 16-week double-blind treatment period because of adverse reactions compared to 4.3% of patients treated with placebo.
Source: Optinose; September 18, 2017.