The major causes of hospital admission and readmission of patients with chronic kidney disease, cirrhosis, or congestive heart failure are fluid overload and edema. About 6.7 million people in the United States are living with heart failure, and fluid retention accounts for over one million hospital admissions annually, adding billions of dollars in healthcare costs. Orally administered loop diuretics are difficult to optimize due to inconsistent gastrointestinal absorption and delayed onset of action, while intravenous formulations require clinical administration, leading to higher resource utilization and increased costs.
ENBUMYST™ (bumetanide nasal spray) is a newly approved drug from the U.S. Food and Drug Administration (FDA) for use in adult patients. This is an intranasal loop diuretic, which is used to treat edema caused by congestive heart failure, hepatic diseases, and kidney diseases like nephrotic syndrome.
Clinical trials indicated that ENBUMYST was absorbed more quickly and had a consistent diuretic effect that produced a comparable effect of diuresis, natriuresis, and excretion of urinary potassium as intravenous bumetanide. ENBUMYST can fill the gap in the treatment of edema in patients with heart failure, liver disease, and kidney disease with an outpatient treatment option, a nasal spray, that may address treatment gaps between oral and IV diuretics.
The FDA acceptance of ENBUMYST is a major milestone in the edema treatment of patients and clinicians, said Ben Esque, the Chief Executive Officer of Corstasis Therapeutics. Dr. Brian Kolski, Chief Medical Director of Corstasis, noted that ENBUMYST was developed with cardiac specialists in order to address real-world issues faced in outpatient care.
Corstasis intends to introduce ENBUMYST into the U.S. healthcare system in Q4 2025 and will target hepatologists, nephrologists, and cardiologists, as well as outpatient heart failure programs and integrated delivery networks (IDNs). Simultaneously, the company is pursuing an all-encompassing access to the market strategy based on the real-world outcomes data and payer partnerships to enable widespread adoption and reimbursement.
It is estimated that the U.S. outpatient diuretic treatments market against edema associated with congestive heart failure, liver disease, and kidney disease will reach several billion dollars annually. This is driven by the fact that the rates of heart failure and chronic kidney diseases are high, as well as the requirement for therapies to help cut down hospital admissions and readmissions, which are associated with significant costs.
Dr. Anuradha Lala-Trindade, the Director of Heart Failure Research at the Mount Sinai Fuster Heart Hospital located in New York, stated that ENBUMYST™ could transform the standard of care by allowing for outpatient intervention earlier in the patient’s care pathway. This advancement would go a long way in improving patient outcomes, besides contributing to the reduction of the economic pressure on the healthcare system.
References: Corstasis Therapeutics. 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. Accessed Sep 17, 2025. 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
