James Palmer, MD: Reacting to New Findings on EDS-FLU for Chronic Rhinosinusitis

For patients with chronic rhinosinusitis with or without polyps, a nonsurgical treatment option may be around the corner, though the US Food and Drug Administration (FDA) has yet to approve of such an option yet.

Recent findings from ReOpen1 and ReOpen2 studies showed promising results for the ‘exhalation delivery system deliver fluticasone’ system, also known as EDS-FLU (Xhance), as far as improvement in symptoms, exacerbations, and intrasinus opacification.

James Palmer, MD, FARS, director of the division of rhinology at Penn Medicine in Philadelphia, spoke with the HCPLive editorial team about his team’s findings in these studies and their implications for patients with this specific type of chronic rhinosinusitis.

“Because of the way it works, one piece fits in the nose, one piece fits in the mouth, and you blow,” Palmer explained. “And with that blowing, first of all, it puts it in at a higher pressure. But more importantly, your soft palate seals. Because your soft palate seals and the nose cone fits really far up into your nose, you're spraying the steroid into a closed cavity. And because it's going into a closed cavity it gets way far back into the sinuses.”

Palmer noted that fluticasone is a steroid that is known to have few if any systemic side effects, as it does not reach the rest of the body and acts locally. After describing the study’s findings, Palmer discussed the safety profile and noted a general lack of adverse events.

“The only real safety profile issue would be there were a few patients who had epistaxis, which is ‘doctor talk’ for nosebleeds,” Palmer said. Pretty standard, in terms of use of fluticasone.”

Later, Palmer focused on the future for the drug-device combination product.

“The FDA is due to rule on it when they get ready to rule on it, and it's a couple months or so as far as I understand,” Palmer explained. “...The EDS-FLU product is already approved for chronic sinusitis with polyps, so I have a lot of my patients using it. The thing that I think is going to be pretty exciting and interesting is now that there actually is a medical therapy for chronic rhinosinusitis of all forms, with or without polyps.”

To find out more about these recent findings, view the full discussion posted above.

The quotes contained in this summary were edited for clarity.