A discussion on the recent success of phase 3 trials regarding chronic sinusitis and nasal polyp treatment.
In an interview with HCPLive, James Palmer, MD, FARS, discussed his recent presentation of phase 3 clinical trial data on a new drug-device combination product designed to treat chronic rhinosinusitis (CRS).
Palmer described the product’s use as an exhalation delivery system for a corticosteroid known as fluticasone propionate, working as a nasal spray for patients with rhinosinusitis. It is referred to as EDS-FLU. Palmer’s presentation of the trial data on the product was presented at the American Rhinologic Society Annual Meeting.
His podium presentation at the meeting was entitled “Re-Open-1: A randomized double-blind placebo-controlled trial of EDS-FLU for CRSwNP or CRSsNP,” and described the ways in which the clinical trials being discussed met both primary endpoints.
“The bulk of our work is with chronic sinusitis,” Palmer said. “Topical steroids have always been the mainstay of treatment. The problem is topical steroids, before EDS-FLU, which stands for exhalation delivery system fluticasone. Before that, the sprays really just dumped down on the inferior turbinate.”
Palmer then described how while nasal sprays prior to this new product helped, chronic sinusitis was not being treated properly due to its effects on the sinuses deep into the nasal cavity.
“So, once we actually had a delivery system that would get topical steroid, one that we knew was probably going to work well, into those sinuses, we were going to have a lot of success,” Palmer said. “I have to admit having been using it for patients with nasal polyps, this was actually my expectation.”
Palmer added that if there was one element of the successful phase 3 trials that surprised him, it was that the product had a 70% or greater decrease in breakthrough events.
View the full interview with Dr. Palmer above to learn more about the clinical trial results.