The US Food and Drug Administration (FDA) has approved budesonide oral suspension (Eohilia, Takeda), the first oral treatment for eosinophilic esophagitis (EoE).
Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years.
It will be available in 2-mg/10-mL single-dose stick packs by the end of February.
"Developed specifically for EoE, Eohilia's novel formulation of budesonide confers thixotropic properties – flowing more freely when shaken and returning to a more viscous state when swallowed," the company said in a news release.
"Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With Eohilia, it's gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms," Ikuo Hirano, MD, professor of medicine and director of the Esophageal Center at Northwestern University Feinberg School of Medicine, Chicago, said in the release.
Supporting Data
The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies.
In Study 1, significantly more patients receiving active treatment achieved histologic remission (53.1% vs 1% with placebo). The same was true in Study 2, with 38% of patients receiving active treatment achieving histologic remission compared with 2.4% of those receiving placebo.
The absolute change from baseline in the patient-reported Dysphagia Symptom Questionnaire combined score was -10.2 with budesonide vs -6.5 with placebo in Study 1 and -14.5 vs -5.9 in Study 2.
During the last 2 weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only experienced dysphagia that "got better or cleared up on its own" compared with those receiving placebo, the company said.
The most common adverse reactions seen in the clinical trials of budesonide oral suspension for EoE included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%).
Complete prescribing information is available online.