FDA
Enbumyst OK’d for heart failure-associated edema
Brand name: Enbumyst
Generic name: bumetanide nasal spray
Manufacturer: Corstasis Therapeutics
Approval date: September 15, 2025
FDA has approved Enbumyst (bumetanide nasal spray), a loop diuretic indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults.
Efficacy
According to a manufacturer press release, Enbumyst demonstrated rapid absorption and predictable diuretic response in clinical studies, with a similar effect on diuresis, natriuresis, and urinary potassium excretion compared with IV bumetanide injection.
Safety
The most common adverse reactions (incidence >0.5%) are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease).
Recommended dose
The recommended total daily dosage of Enbumyst is 0.5 mg to 2 mg once daily. Enbumyst isn’t intended for chronic use; it should be replaced with oral diuretics as soon as practical.
Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause.
Sources:
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]. 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
Enbumyst (bumetanide nasal spray) [package insert]. Corstasis Therapeutics. https://corstasis.com/wp-content/uploads/2025/09/Enbumyst_bumetanide_nasal_spray_PI_12Sept25.pdf Revised September 2025. Accessed September 16, 2025.