FDA Approves Cortasis Nasal Spray, Enbumyst, for Edema

Close up shot pharmacist holding nasal spray medicine at the drugstore.Seasonal health issues | Image Credit: © I Viewfinder - stock.adobe.com

Nevada-based Corstasis Therapeutics (Corstasis) has announced FDA’s approval of its bumetanide nasal spray, Enbumyst, for the treatment of edema associated with congestive heart failure (CHF) and both hepatic and renal disease, including nephrotic syndrome in adults (1).

Why is a nasal spray beneficial?

With approximately 6.7 million Americans living with heart failure, and associated fluid overload causing more than 1 million hospitalizations every year, accounting for billions of dollars in United States healthcare expenditures, Corstasis said the nasal spray addresses a critical unmet need; together, fluid overload and edema are the leading causes of hospitalization—and readmission—for patients with CHF, cirrhosis, and chronic kidney disease (1).

A nasal spray treatment for edema in these patients, Corstasis said, may help bridge the gap between oral loop and intravenous (IV) diuretics. The former can be limited by delayed onset and poor gastrointestinal absorption, while the latter requires administration in a hospital or infusion setting, using resources and increasing healthcare expenditures (1). Conversely, Enbumyst has been designed as an outpatient, self-administered therapy.

In clinical studies, according to Corstasis, the nasal spray demonstrated rapid absorption and predictable diuretic response, showing comparable effects on diuresis, natriuresis, and urinary potassium excretion in comparison to IV bumetanide injection (1).

What are the experts saying?

A press release from Corstasis Therapeutics encapsulated the reactions of numerous industry professionals with knowledge of the nasal spray’s potential.

“Enbumyst offers the potential to change the standard of care by enabling earlier, outpatient intervention,” said Anuradha Lala-Trindade, MD, director of Heart Failure Research at the Mount Sinai Fuster Heart Hospital in New York, in the press release (1). “This innovation may meaningfully improve outcomes while potentially easing the economic burden on the healthcare system.”

“Enbumyst was designed in direct collaboration with cardiologists to address practical challenges in the outpatient care setting,” said Brian Kolski, MD, chief medical director of Corstasis, director of the Non-Invasive Vascular Lab at the Orange County Heart Institute, and director of Structural Heart Disease at Providence St. Joseph Hospital in Orange, Calif. (1).

“The FDA approval of Enbumyst represents a meaningful advancement in the treatment of edema for patients and providers,” said Ben Esque, chief executive officer of Corstasis Therapeutics (1).

Are other effective nasal sprays emerging on the market?

Another nasal spray, ARS Pharmaceuticals’ epinephrine nasal spray Neffy (commercialized outside the US, Australia, New Zealand, Japan, and China by ALK as EURneffy), had a first large-scale analysis demonstrating real-world, clinical evidence of treatment outcomes accepted for publication as correspondence in the Annals of Allergy, Asthma and Immunology, ARS Pharma announced on Sept. 8, 2025 (2,3). The nasal spray’s performance was observed in routine clinical practice in patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy.

Learn more about the findings in that analysis, and the other top Pharmaceutical Technology® stories from the week of Sept. 8, in the “PharmTech Weekly Roundup” accessible at this link.

Corstasis said it expects to launch Embumyst in the US in the fourth quarter of 2025, and will target cardiologists, nephrologists, hepatologists, outpatient heart failure clinics, and integrated delivery networks (1).

References

1. 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. Press Release. Sept. 15, 2025.
2. ARS Pharmaceuticals. Real-World Evidence Supports Clinical Effectiveness of Neffy (epinephrine nasal spray) in Patients Experiencing Anaphylaxis. Press Release. Sept. 8, 2025.
3. Lavery, P. Epinephrine Nasal Spray Comparable to Injection in Real-World Data of Patients Experiencing Anaphylaxis. PharmTech.com, Sept. 9, 2025.