Corstasis Therapeutics Announces
Corstasis Therapeutics Announces FDA Approval of ENBUMYST™ (bumetanide nasal spray) for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease
HENDERSON, Nev. -- Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, today announced that the U.S. Food and Drug Administration (FDA) has approved ENBUMYST™ (bumetanide nasal spray). ENBUMYST is indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults.
Edema and fluid overload remain the leading causes of hospitalization and readmission for patients with CHF, cirrhosis, and chronic kidney disease. An estimated 6.7 million Americans live with heart failure, and fluid overload drives over 1 million hospitalizations annually, accounting for billions of dollars in U.S. health care expenditures. Oral loop diuretics can be limited by poor gastrointestinal absorption and delayed onset, while intravenous (IV) therapy requires a hospital or infusion setting, often associated with higher resource utilization and increased healthcare expenditure.
ENBUMYST demonstrated rapid absorption and predictable diuretic response in clinical studies, with a similar effect on diuresis, natriuresis and urinary potassium excretion when compared to IV bumetanide injection. ENBUMYST adds a new self-administered outpatient diuretic therapy, which may help bridge the gap between oral and IV diuretics for treating edema in patients with CHF, liver disease and kidney disease. The FDA-approved Prescribing Information for ENBUMYST does not include a boxed warning.
Commercial Strategy and Market Opportunity
Corstasis expects to launch ENBUMYST in the U.S. in the fourth quarter of 2025, targeting cardiologists, nephrologists, hepatologists, outpatient heart failure clinics and integrated delivery networks (IDNs). The company is also preparing a robust market access strategy, including real-world outcomes data and payer partnerships, to support rapid adoption and coverage.
The U.S. market for outpatient diuretic therapies addressing edema associated with CHF, and hepatic and renal disease is estimated to represent a multi-billion-dollar opportunity annually, driven by the high prevalence of heart failure and chronic kidney disease, as well as the unmet need for therapies that reduce costly hospitalizations and readmissions.
“ENBUMYST offers the potential to change the standard of care by enabling earlier, outpatient intervention,” said Dr. Anuradha Lala-Trindade, Director of Heart Failure Research at the Mount Sinai Fuster Heart Hospital in New York. “This innovation may meaningfully improve outcomes while potentially easing the economic burden on the healthcare system.”
ENBUMYST is a nasal spray loop diuretic indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults. ENBUMYST is contraindicated in patients with anuria, who are in hepatic coma and have a history of hypersensitivity to bumetanide.
