Enbumyst demonstrated rapid absorption and predictable diuretic response comparable to intravenous bumetanide in clinical studies.

The US Food and Drug Administration approved Enbumyst (bumetanide nasal spray) for the treatment of edema associated with congestive heart failure, hepatic disease, and renal disease, including nephrotic syndrome in adults, according to Corstasis Therapeutics. Enbumyst is the first intranasal loop diuretic available in the US and provides a self-administered option between oral and intravenous diuretics.

Edema and fluid overload remain leading causes of hospitalization and readmission among patients with heart failure, cirrhosis, and chronic kidney disease. Oral loop diuretics can be limited by variable gastrointestinal absorption and delayed onset of action, while intravenous formulations require administration in hospital or infusion settings, contributing to higher health care utilization. In clinical studies, Enbumyst demonstrated rapid absorption and predictable pharmacodynamic effects, including diuresis, natriuresis, and urinary potassium excretion, with outcomes comparable to intravenous bumetanide injection.

Corstasis plans to launch Enbumyst in the fourth quarter of 2025 with a commercial strategy targeting cardiology, nephrology, hepatology, and outpatient heart failure clinics.

Enbumyst is contraindicated in patients with anuria, hepatic coma, or hypersensitivity to bumetanide. Reported risks include electrolyte and metabolic disturbances, dehydration, hypovolemia, and hypotension. Common adverse reactions include headache, muscle cramps, dizziness, nausea, and encephalopathy in patients with preexisting liver disease.

Source: Corstasis Therapeutics