FDA Approves Bumetanide Nasal Spray for Edema With Heart Failure, Hepatic and Renal Disease

The FDA has granted regulatory approval to bumetanide nasal spray (Enbumyst; Corstasis Therapeutics), an outpatient diuretic therapy indicated for the treatment of adults with edema associated with congestive heart failure, liver disease, and kidney disease, including nephrotic syndrome, according to a news release from Corstasis Therapeutics. The approval provides patients dealing with edema a novel alternative to oral loop diuretics or intravenous (IV) therapy, which can carry limitations blunting their effectiveness.¹

“[Bumetanide nasal spray] offers the potential to change the standard of care by enabling earlier, outpatient intervention,” Anuradha Lala-Trindade, MD, director of heart failure research at the Mount Sinai Fuster Heart Hospital, said in the news release. “This innovation may meaningfully improve outcomes while potentially easing the economic burden on the health care system.”¹

Edema is caused by excess fluid throughout the body. | Image Credit: © Jiraporn - stock.adobe.com

What is Edema?

Edema presents as swelling induced by excess fluid in the body’s tissues. Though it often occurs in the feet, ankles, and legs, edema can appear throughout the entire body. A major cause of edema is the presence of severe, chronic conditions—like renal and hepatic disease—which contribute to fluid buildup. For example, in congestive heart failure, the reduced effectiveness of the heart causes fluid to build up in the lungs and other areas of the body, with swelling visible in the feet or ankles.^1,2

For patients with such conditions, edema and fluid overload are leading causes of hospitalization and subsequent readmission. Oral loop diuretics, for which a series of products are approved by the FDA for the treatment of edema, are recommended in the treatment of edema to reduce morbidity. They work by inhibiting salt reabsorption, allowing for greater water excretion and reducing swelling. However, adverse effects are possible with the use of such diuretics, including poor gastrointestinal absorption and delayed onset. Furthermore, IV diuretics require an inpatient hospital or infusion setting, which is associated with higher health care spending and more intensive resource utilization. Resistance to such products is also a palpable concern, necessitating more effective options.^1,3

How Bumetanide Nasal Spray Fills Treatment Gaps for Patients With Edema

Bumetanide nasal spray helps address a major unmet need for patients with edema and fluid overload, with the product demonstrating rapid absorption and a predictable diuretic response in clinical trials. The product was designed for absorption through nasal mucosa, with investigators claiming that it can provide more consistent bioavailability. In one open-label, randomized, controlled trial in healthy volunteers, bumetanide nasal spray demonstrated bioequivalence and robust bioavailability compared with oral and IV bumetanide. Critically, the nasal spray induced a similar effect on diuresis, natriuresis, and urinary potassium excretion compared with the other formulations.¹

The new nasal spray can be self-administered in an outpatient setting, which allows for more effective administration and a more tolerable experience for patients compared with alternative options. Although patients may still require oral and IV diuretics in hospital settings if they are admitted, bumetanide nasal spray can help patients bridge gaps in treatment for their edema and allow for consistent work towards swelling reduction. The product is expected to be available in multiple health care settings, including specalist offices, outpatient heart failure clinics, and integrated delivery networks.¹

Given the extensive expected reach of bumetanide nasal spray, pharmacists will play a major role in ensuring access for patients and counseling them on how to use the product. If a pharmacist observes swelling due to edema in a patient visiting their facility, they can make a recommendation to the patient to consider a diuretic that may help reduce their swelling and fluid overload. In addition, pharmacists are essential in reviewing the safety information associated with the spray, including the listed contraindications for patients with anuria or who are in hepatic coma and the risk of fluid, electrolyte, or metabolic abnormalities.¹

“The FDA approval of [bumetanide nasal spray] represents a meaningful advancement in the treatment of edema for patients and providers,” Ben Esque, CEO of Corstasis Therapeutics, said in the news release.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. BusinessWire. News Release. Published September 15, 2025. Accessed September 16, 2025. https://www.businesswire.com/news/home/20250915243998/en/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

2. Shmerling RH, MD. Leg edema. Harvard Health Publishing. Updated June 13, 2025. Accessed September 16, 2025. https://www.health.harvard.edu/diseases-and-conditions/edema-a-to-z

3. Ambrosy AP, Bensimhon D, Bernstein G, et al. Randomized Study Comparing a Novel Intranasal Formulation of Bumetanide With Oral and Intravenous Formulations. Circulation. 2024;151(10). doi:10.1161/CIRCULATIONAHA.124.072949