Corstasis Therapeutics Gains FDA Approval for ENBUMYST™ (Bumetanide Nasal Spray) to Treat Edema Linked to Heart, Liver and Kidney Disease
Tuesday, September 16, 2025
Corstasis Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for ENBUMYST™ (bumetanide nasal spray). The treatment is indicated for oedema linked to congestive heart failure (CHF), liver disease, and kidney disease, including nephrotic syndrome in adults.
Oedema and fluid overload are major causes of hospitalisation and readmission for patients with CHF, cirrhosis, and chronic kidney disease. In the United States, around 6.7 million people live with heart failure, with fluid overload responsible for more than one million hospitalisations each year. This contributes significantly to healthcare costs.
Current treatment options include oral loop diuretics, which may have limitations such as poor absorption and delayed onset, and intravenous (IV) therapies, which require hospital or infusion settings and lead to higher resource use.
Clinical studies have shown that ENBUMYST delivers rapid absorption and a predictable diuretic effect, comparable to IV bumetanide injection in terms of diuresis, natriuresis and urinary potassium excretion. The nasal spray provides a self-administered outpatient therapy that bridges the gap between oral and IV diuretics. The FDA-approved prescribing information for ENBUMYST does not carry a boxed warning.
Corstasis plans to launch ENBUMYST in the United States in the fourth quarter of 2025. The product will be introduced to cardiologists, nephrologists, hepatologists, outpatient heart failure clinics and integrated delivery networks (IDNs). Alongside the launch, the company is preparing a market access strategy supported by real-world data and partnerships with payers to encourage broad adoption.
The U.S. market for outpatient diuretic therapies addressing oedema in CHF, liver disease and kidney disease is considered a multi-billion-dollar opportunity. High disease prevalence, combined with the need for therapies that help reduce costly hospital admissions, is expected to drive demand for ENBUMYST.
The approval of ENBUMYST represents a step towards improving outpatient care for patients with cardiovascular and renal conditions, with potential to reduce hospitalisations and ease pressure on healthcare systems.
Source: businesswire.com
