FDA

Enbumyst OK’d for heart failure-associated edema

September 17, 2025

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.