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Budesonide oral suspension presents as a reliable FDA-approved therapy for the relief of eosinophilic esophagitis, backed by robust clinical data and a favourable safety profile.
First Budesonide oral suspension for eosinophilic esophagitis (EoE) (available as 2-mg/10-mL single-dose stick packs) is now approved by the US FDA in people aged 11 years and older, as per a news release in February 2024.
This novel therapy marks a significant milestone with its FDA-approved formulation, ensuring consistent dosing and efficacy in combatting esophageal inflammation and EoE-related swallowing difficulties.
Touted as a breakthrough for EoE, this Budesonide oral suspension has unique thixotropic qualities, allowing it to flow smoothly when disturbed and regain viscosity upon ingestion, ensuring reliable dosing.
This approval is grounded upon efficacy and safety data from two 12-week clinical studies comprising individuals with EoE, details as under:
Study 1:
EoE patients aged 11 to 56 years were randomized into two groups: An intervention group with Budesonide oral suspension 2 mg given twice daily and a placebo group with oral twice daily. Considerably more patients in the intervention group accomplished histologic remission (53.1% versus 1% with placebo).
The absolute change from the start of the intervention in the Dysphagia Symptom Questionnaire (DSQ) score was -10.2 with Budesonide compared to -6.5 with the placebo.
Study 2:
EoE patients aged 11 to 42 years were randomized into two groups: An intervention group with Budesonide oral suspension 2 mg given twice daily and a placebo group with oral twice daily. Considerably more patients in the intervention group accomplished histologic remission (38% versus 2.4% with placebo).
The absolute change from the start of the intervention in the DSQ score was -14.5 with Budesonide vs -5.9 with the placebo.
In both studies, more patients receiving Budesonide oral suspension encountered no difficulty in swallowing (dysphagia) or just had dysphagia that improved or completely healed during the last 2 weeks of the clinical study.
Respiratory tract infection (13%), gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis (2%) were ordinarily observed adverse events.
Medscape
FDA OKs First Oral Agent for Eosinophilic Esophagitis
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