Corstasis Therapeutics Gains FDA Approval for ENBUMYST Nasal Spray to Treat Edema

What's Happening?

Corstasis Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has approved ENBUMYST, a bumetanide nasal spray, for the treatment of edema associated with congestive heart failure, liver disease, and kidney disease. ENBUMYST is the first intranasal loop diuretic approved in the U.S., offering a self-administered alternative to oral and intravenous diuretics. The approval addresses a significant unmet need, as edema and fluid overload are leading causes of hospitalization for patients with these conditions. Clinical studies have shown that ENBUMYST provides rapid absorption and a predictable diuretic response, similar to intravenous bumetanide injections.

Why It's Important?

The approval of ENBUMYST represents a significant advancement in outpatient care for patients with cardiovascular and renal diseases. By providing a self-administered option, it could reduce the need for hospitalizations and associated healthcare costs, which are substantial due to the high prevalence of heart failure and chronic kidney disease in the U.S. The introduction of ENBUMYST may improve patient outcomes by enabling earlier intervention and reducing the economic burden on the healthcare system. This innovation is expected to be well-received by cardiologists, nephrologists, and other healthcare providers involved in managing these conditions.

What's Next?

Corstasis Therapeutics plans to launch ENBUMYST in the U.S. market in the fourth quarter of 2025. The company is preparing a comprehensive market access strategy, including partnerships with payers and real-world outcomes data, to support rapid adoption and coverage. The market for outpatient diuretic therapies is estimated to be a multi-billion-dollar opportunity annually, driven by the need for effective treatments that reduce costly hospitalizations and readmissions. Corstasis is also developing a pipeline of subcutaneous diuretic products to further enhance outpatient therapeutic options.