The US Food and Drug Administration (FDA) has approved the first intranasal diuretic for heart, liver and kidney disease patients, aiming to prevent a common and costly issue that results in more than a million hospitalizations each year.
Enbumyst, a bumetanide nasal spray developed by Corstasis Therapeutics, is the first intranasal loop diuretic to be cleared for use in the US. The therapy is indicated for the treatment of edema associated with congestive heart failure, liver disease and kidney disease, including nephrotic syndrome, in adults.
Edema and fluid overload are among the most common and costly complications of chronic illness, leading to more than one million hospital admissions each year in the US alone. Oral diuretics are widely prescribed but can be limited by poor absorption and delayed onset, while intravenous (IV) diuretics require hospital or infusion center administration.
The new nasal spray, Enbumyst, is designed to bridge the gap, offering patients a self-administered outpatient option to prevent reliance on the hospital system. In clinical studies conducted between December 2023 and April 2024, featuring 68 adults aged 18 to 55 years, the nasal spray demonstrated rapid absorption and a predictable diuretic effect comparable to IV bumetanide, including similar impacts on urine volume, sodium excretion and potassium levels. The therapy may allow earlier intervention outside the hospital, potentially reducing readmissions and easing the financial burden on the healthcare system.
“The FDA approval of Enbumyst represents a meaningful advancement in the treatment of edema for patients and providers,” said Ben Esque, Chief Executive Officer of Corstasis Therapeutics.
The therapy could shift the standard of care for heart failure patients in particular. The drug had a robust safety and tolerability record throughout the clinical trial stages, with the most common side effects reported being hypovolemia, headache, muscle cramps, dizziness and nausea.
“[Bumetanide nasal spray] offers the potential to change the standard of care by enabling earlier, outpatient intervention,” said Anuradha Lala-Trindade, MD, the director of heart failure research at the Mount Sinai Fuster Hospital in New York. “This innovation may meaningfully improve outcomes while potentially easing the economic burden on the healthcare system.”
Corstasis Therapeutics is expected to launch Enbumyst in late 2025.
Source: Corstasis Therapeutics via Business Wire
