FDA Accepts New Drug Application for Bumetanide Nasal Spray

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has accepted the New Drug Application for Bumetanide Nasal Spray, assigning a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025.¹

Announced by Corstasis Therapeutics Inc. on January 27, 2025, bumetanide nasal spray is an investigational drug in development as an outpatient-focused therapy for edema associated with congestive heart failure, as well as liver and kidney disease

“We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray,” Benjamin Esque, CEO of Corstasis Therapeutics, said in a statement.¹ “This milestone brings us closer to providing a simple, easy-to-use outpatient therapy for patients with fluid overload. We look forward to working closely with the FDA throughout the review process.”

Bumetanide is a standard diuretic administered orally or intravenously to reduce tissue swelling from heart, kidney, or liver disease, with the removal of excess salt and water through the urine. Bumetanide nasal spray was designed to enable patients to self-administer non-oral loop diuretic therapy through the nasal mucosa in an outpatient setting.

Presented as late-breaking science at the American Heart Association (AHA) Scientific Sessions 2024, the RSQ-777-02 trial was conducted between December 2023 and April 2024 at the Orange County Research Center. The RSQ-777-02 clinical trial evaluated a nasal spray form of bumetanide in 68 healthy adults, without heart failure or related risk factors at enrollment. Investigators compared the absorption and ability to reduce swelling of bumetanide nasal spray versus the same effects of oral and intravenous (IV) bumetanide.²

Among the study population, more than half (66.3%) of participants were male and most (60.3%) were White. The study administered nasal, oral, and intravenous bumetanide to each participant in a varied order and monitored study participants on-site for 10 days.

Analysis showed bumetanide nasal spray was absorbed effectively and remained tolerable, showing consistent side effects with other administrations and fewer treatment-emergent adverse events (TEAEs) than the oral version. Bumetanide nasal spray achieved a similar amount of urine output and blood concentration to oral and IV bumetanide, with a 33% faster absorption rate.

Absorption of IV bumetanide outpaced both oral and nasal bumetanide, but the onset of sodium excretion in urine was faster with the nasal form, according to these data. In addition, the nasal and IV forms of bumetanide were absorbed at more reliable rates than the oral form for each participant, who ultimately received all 3 forms of bumetanide.

Overall, nasal and IV bumetanide demonstrated variability of absorption of 27%, compared with >40% for the oral form, pointing to the greater stability of the nasal and IV forms and the advantage of the nasal spray over the oral form for at-home self-administration.

“Our aim is to reduce the burden on both patients and the healthcare system by offering treatment options outside the hospital setting—potentially lowering costs and improving quality of life,” Brian Kolski, MD, chief medical officer of Corstasis Therapeutics Inc., said in a statement.¹

References

1. _{Corstasis Therapeutics Inc.. announces FDA acceptance of New Drug Application for bumetanide nasal spray. Business Wire. January 27, 2025. Accessed January 27, 2025. https://www.businesswire.com/news/home/20250126982238/en/Corstasis-Therapeutics-Inc.-Announces-FDA-Acceptance-of-New-Drug-Application-for-Bumetanide-Nasal-Spray.}
2. _{Iapoce C. Bumetanide nasal spray equivalent to oral, IV forms for heart failure. HCP Live. January 27, 2025. Accessed January 27, 2025. https://www.hcplive.com/view/bumetanide-nasal-spray-equivalent-to-oral-iv-forms-for-heart-failure.}