Methods of treating eosinophilic esophagitis and reducing candidiasis
AssigneeEllodi Pharmaceuticals, L.P.
InventorsJames Nezamis, Gina Eagle, Mark Marino, Peter Richardson
Life of this patent
Estimating the term…
Abstract
Disclosed herein are methods for treating eosinophilic oesophagitis with corticosteroids. The methods for treating eosinophilic oesophagitis disclosed herein result in reduced corticosteroid side effects, e.g. candidiasis. Dosages, formulations, and methods for administration of corticosteroids are provided.
Claims32
A method of treating eosinophilic esophagitis (EoE) in a patient in need thereof comprising administering to the patient an orally disintegrating tablet (ODT) comprising about 1.5 mg to about 3 mg of fluticasone propionate, wherein the ODT is orally administered once daily for at least 12 weeks, wherein at Week 12:
- a. the patient's risk of candidiasis is less than about 10%, and
- b. the patient shows an improvement in at least one of the following outcomes compared to a patient that is administered the fluticasone propionate twice daily:
- i. at least one symptom score measured using a patient reported outcome symptom evaluation (PROSE) instrument after an episode of dysphagia;
- ii. EoE Endoscopic Reference (EREFS) score;
- iii. EoE Activity Index (EEsAI) avoidance, modification, and slow swallowing (AMS) score;
- iv. Global EoE score;
- v. Patient global impression of severity (PGIS);
- and
- vi. Patient global impression of change (PGIC).
Dependencies are inferred from the claim text.