Corstasis’ Enbumyst nasal spray approved for edema

1. First intranasal loop diuretic approved by the FDA for heart, kidney, and liver disease patients.
2. Clinical trials showed comparable efficacy to intravenous dosing with more convenient outpatient use.

The Food and Drug Administration has approved Enbumyst, a bumetanide nasal spray, for adults with edema caused by congestive heart failure, chronic kidney disease, and liver disease. It is the first intranasal loop diuretic cleared in the United States, offering a new delivery format between oral and intravenous therapies. More than 6.7 million Americans live with heart failure, and fluid overload results in more than one million hospitalizations each year. In clinical studies, Enbumyst achieved natriuresis comparable to intravenous bumetanide within two hours, while oral formulations showed absorption variability of over 40 percent. Corstasis expects to launch the product later this year and has projected multi-billion dollar annual sales. Common adverse events included dizziness, hypovolemia, cramps, and nausea, consistent with other loop diuretics. Physicians may see this as a practical outpatient option that could help reduce emergency visits and repeat hospitalizations. Specialists note that therapies which prevent hospital readmissions are increasingly valued in both clinical and reimbursement frameworks. The approval also reflects growing interest in drug-device hybrids that make established drugs easier to use. Uptake may depend on payers’ willingness to reimburse and how quickly physicians integrate it into existing treatment pathways. For many patients with recurrent fluid overload, a nasal spray may represent a meaningful improvement in quality of life and access to care.

Image: PD

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