A topical formulation of fluticasone designed to dissolve and coat the esophagus appears safe and effective for the treatment of eosinophilic esophagitis (EOE), according to new results from a phase 2b study. The results pave the way for phase 3 clinical trials.
Topical steroids are frequently used off-label for EOE. They may be repurposed from nebulizers used for asthma, with patients mixing the drugs themselves or sending them to a pharmacy to be compounded. Patients remove the spacer from a nebulizer in order to swallow the active compound or mix the liquid that would be nebulized with honey or Splenda to thicken it to maximize its contact with the esophagus. "Both of these things are very cumbersome and difficult. I get a lot of complaints from patients [that] it doesn't taste good. So, the fact that we have a drug that we are already using, but it's designed for the esophagus, is really exciting," said Nielsen Fernandez-Becker, MD, PhD, of the department of gastroenterology and hepatology at Stanford (Calif.) University. Fernandez-Becker referred some patients to the trial and performed some procedures.
"I don't think the findings are unexpected, given what we've seen with swallowed inhalers with fluticasone, but I think the real importance of this is that it does look like a dedicated swallow form works.