FDA approval has been granted for ENBUMYST™ (bumetanide nasal spray), a new drug from Corstasis Therapeutics for the treatment of edema in adults with congestive heart failure, liver, and kidney disease. This is a significant development as ENBUMYST™ is the first and only intranasal loop diuretic approved in the U.S., offering a self-administered alternative to current treatments. This new option may help address a critical unmet need in healthcare, as edema and fluid overload are the leading causes of hospitalizations and readmissions for patients with these conditions. Current oral diuretics can have poor absorption and delayed effects, while intravenous (IV) therapy requires a hospital or infusion setting, both of which contribute to billions of dollars in U.S. healthcare expenditures each year.

Clinical studies showed that ENBUMYST™ is rapidly absorbed and provides a predictable diuretic response, with similar effects to IV bumetanide. This new self-administered outpatient therapy bridges the gap between less-effective oral medications and costly IV treatments, potentially changing the standard of care by enabling earlier intervention. Corstasis Therapeutics plans to launch ENBUMYST™ in the U.S. in the fourth quarter of 2025, targeting cardiologists, nephrologists, hepatologists, and heart failure clinics. The company expects the U.S. market for this therapy to be a multi-billion-dollar opportunity, driven by the high prevalence of these diseases and the clear need for treatments that reduce hospitalizations and costs. The FDA-approved prescribing information for ENBUMYST™ does not include a boxed warning, but notes that it is contraindicated in patients with anuria or hepatic coma and may cause side effects like dehydration, electrolyte imbalances, and hypotension.