The USFDA has approved budesonide oral suspension, the first and only FDA-approved oral therapy for the treatment of patients aged 11 years and older with eosinophilic esophagitis. Budesonide is a corticosteroid indicated for 12 weeks of treatment. Its efficacy and safety were demonstrated in two 12-week studies, with a significant increase in histologic remission.
Clinical trial Efficacy and safety of the drug was tested in two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies, Study 1 and Study 2, in patients aged 11 to 56 and 11 to 42, respectively. Patients receiving budesonide achieved significant histologic remission up to 53.1% and 38% compared to the placebo in two studies, with improved Dysphagia Symptom Questionnaire scores. Dosage and administration 2 mg/10 mL, twice daily Adverse reactions Respiratory tract infection Gastrointestinal…
