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About Budesonide
Budesonide is the active pharmaceutical ingredient in several products approved by the U.S. Food and Drug Administration (FDA), including products for the treatment of pediatric asthma, allergic rhinitis and Crohn's disease. Budesonide is a glucocorticoid steroid and has an established safety profile in those diseases and works by decreasing inflammation in the treated area.
About Oral Viscous Budesonide
Oral viscous budesonide (OVB) is a proprietary oral formulation of budesonide for the potential treatment of patients with eosinophilic esophagitis (EoE). OVB is designed to coat the esophagus with budesonide in order to treat local eosinophilic inflammation and provide patients symptomatic relief.
The FDA has granted Orphan Drug Status designation to OVB for the treatment of pediatric EoE. Orphan designation generally provides Meritage Pharma with market exclusivity for the product for seven years following FDA approval, in addition to other incentives. There are currently no FDA-approved products for the treatment of EoE.
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