Enbumyst (bumetanide nasal spray), developed by Corstasis Therapeutics, has received approval from the U.S. Food and Drug Administration (FDA). It is the first intranasal diuretic approved for the treatment of edema associated with congestive heart failure, hepatic disease, and renal disease, including nephrotic syndrome, in adults.
About the Product
Since its initial FDA approval in 1983, bumetanide has been marketed as injectable and oral tablets before being made available as the nasal spray Enbumyst. In the fourth quarter of 2025, the recently authorised spray will be accessible in the US. It makes use of Aptar Pharma’s Unidose System, a delivery method that is presently found in over 30 medications that have received FDA and EMA approval.
Clinical Data
Clinical pharmacology studies involving 68 adult patients served as the foundation for the FDA’s approval. Based on diuresis, natriuresis, and potassium excretion, the results showed a comparable level of efficacy to both oral and intravenous formulations, as well as a faster absorption rate (33% higher than oral bumetanide).
Two studies with 84 participants assessed safety. Headache (3%) and hypovolemia (4.8%) were among the reported adverse reactions. Throughout treatment, it is recommended to monitor renal function, electrolytes, and fluid balance.
Indication & Administration
- Enbumyst is recommended for adults with oedema brought on by liver, kidney, or heart disease.
- Recommended dosage range from 0.5 to 2 mg once daily, with adjustments based on patient response.
- It must be used with alternating nostrils and under a doctor’s supervision.
- The medication is not meant for long-term use and is not a substitute for D-penicillamine.
Clinical & Public Health Context
Nearly 50% of patients with liver or kidney disease and up to 20% of patients with heart failure experience oedema. In these populations, it is among the main reasons for readmissions to hospitals. In addition to oral and intravenous diuretics, Enbumyst offers a self-administered nasal delivery option.
References
- FDA approval
- FDA approval update – Corstasis Therapeutics, BusinessWire (2025).
- Aptar Pharma – Unidose System approval announcement, BioSpace (2025).
- Drugs.com – Enbumyst drug history and prescribing information.
FiercePharma – FDA approval coverage on Enbumyst, 2025.
