FDA Approves Bumetanide Nasal Spray for Edema Associated With Heart Failure, Liver Disease

The FDA approved bumetanide nasal spray (Enbumyst) for the treatment of edema associated with congestive heart failure and hepatic and renal diseases, including nephrotic syndrome. This marks the first approval of an intranasal loop diuretic for these indications. Bumetanide nasal spray is available in 0.5 mg, which is an alternative to traditional oral and intravenous formulations for outpatient therapies.^1,2

"Enbumyst 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 in New York, said in a news release.¹ “This innovation may meaningfully improve outcomes while potentially easing the economic burden on the health care system.”

Edema is caused when there is too much fluid trapped in body tissue, and it can affect any part of the body. However, it is more likely to manifest in the legs and feet. Although medications and pregnancy can cause edema, it can also be caused by congestive heart failure, kidney disease, venous insufficiency, or cirrhosis of the liver. Symptoms include swelling or puffiness of the tissue under the skin, stretched or shiny skin, skin that holds a dimple, and feeling of leg heaviness, according to the Mayo Clinic.³

In a letter published in Circulation, the authors discuss resistance to oral diuretics and how it could contribute to acute decompensated heart failure. They state, “Fewer than 1% of outpatient encounters involve parenteral diuretic therapy, largely because of access limitations. Therefore, intravenous (IV) diuretics are typically required, necessitating inpatient management.”⁴

Investigators conducted an open-label, randomized controlled trial for healthy individuals to compare the bioavailability of the nasal spray with the oral tablet and IV formulation. There were 68 individuals included in the study, with 66 finishing the study. In total, investigators included 132 complete pharmacokinetic/pharmacodynamic profiles. The average age was 39 years, and 34% were female. Further, 60% of individuals were white, 28% were Black, 10% were Asian, and 12% were Hispanic.⁴

The nasal spray met the primary end point, which showed bioequivalence for the oral formulation for the Cmax, AUC0-t, and AUC0-inf, according to the authors. Furthermore, investigators noted that the nasal spray was absorbed more rapidly, with a median time to maximum of 1 hour compared with 1.5 hours for the oral formulation. As for pharmacodynamics, the effects on diuresis and natriuresis were comparable for the nasal spray and IV and oral formulations.⁴

Approximately 38.2% of individuals experienced at least 1 treatment-emergent adverse event (TEAE), with a total of 38 being reported. The most common included hypovolemia and headache. No TEAEs were considered severe, life-threatening, or fatal. The authors of the letter stated, “Additional research is needed to evaluate its role in diverse populations and acute decompensated heart failure.”⁴

READ MORE: FDA Updates Resource Center

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REFERENCES

1. 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. News release. Corstasis. September 15, 2025. Accessed September 19, 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. Aptar Pharma’s unidose system delivers Enbumyst, first US FDA-approved intranasal diuretic. News release. Aptar Pharma. September 18, 2025. Accessed September 19, 2025. https://www.businesswire.com/news/home/20250918312569/en/Aptar-Pharmas-Unidose-System-Delivers-Enbumyst-First-U.S.-FDA-Approved-Intranasal-Diuretic

3. Mayo Clinic. Edema. Updated July 28, 2023. Accessed September 19, 2025. https://www.mayoclinic.org/diseases-conditions/edema/symptoms-causes/syc-20366493

4. Ambrosy AP, Bensimhon D, Bernstein G, et al. Randomized Study Comparing a Novel Intranasal Formulation of Bumetanide With Oral and Intravenous Formulations. Circulation. 2025;151(10):737-740. doi:10.1161/CIRCULATIONAHA.124.072949