FDA approves nasal spray for edema associated with congestive heart failure
Corstasis Therapeutics, a Nevada-based biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) approval for bumetanide nasal spray for the treatment of edema associated with congestive heart failure (CHF), kidney disease and liver disease. This represents the first time an intranasal loop diuretic has been approved by the FDA.
Corstasis Therapeutics is selling bumetanide nasal spray under the brand name Enbumyst. The company believes it will help “bridge the gap” between oral and IV diuretics when patients present with edema.
“The FDA approval of Enbumyst represents a meaningful advancement in the treatment of edema for patients and providers,” Ben Esque, chief executive officer of Corstasis Therapeutics, said in a statement.
“Enbumyst was designed in direct collaboration with cardiologists to address practical challenges in the outpatient care setting,” added Brian Kolski, MD, chief medical director of Corstasis, director of the noninvasive vascular lab at the Orange County Heart Institute and director of structural heart disease at Providence St. Joseph Hospital in Orange, California.
Corstasis Therapeutics is targeting the fourth quarter of 2025 for the official U.S. launch of bumetanide nasal spray. The company plans on focusing its initial push of the product to cardiologists, nephrologists, hepatologists, outpatient heart failure clinics and integrated delivery networks.
Back in March, the FDA chose not to approve etripamil, a nasal spray from Milestone Pharmaceuticals developed for the treatment of adults with heart rhythm issues.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.