AHA: Bumetanide Nasal Spray Statistically Bioequivalent to Oral Bumetanide
By Elana Gotkine HealthDay Reporter
MONDAY, Nov. 25, 2024 -- Bumetanide nasal spray (BNS) has statistical bioequivalence to oral bumetanide, according to a research letter published online Nov. 18 in Circulation to coincide with the American Heart Association Scientific Sessions 2024, held from Nov. 16 to 18 in Chicago.
Andrew P. Ambrosy, M.D., from the Kaiser Permanente San Francisco Medical Center, and colleagues conducted an open-label, randomized controlled trial in healthy volunteers to compare the bioavailability of BNS to that of an oral tablet and intravenous (IV) bumetanide. Sixty-eight participants were assigned to one of four treatment sequences across five treatment periods, with a 48-hour washout period between treatments.
The researchers found that BNS achieved its primary end point, demonstrating statistical bioequivalence to oral bumetanide for maximum concentration, area under the concentration-time curve 0-t, and area under the concentration-time curve 0-inf. BNS was absorbed more rapidly, with a median time to maximum concentration of 1.0 and 1.5 hours for BNS and the oral formulation, respectively. Twenty-seven percent variability in absorption was seen for the nasal and IV forms compared with >40 percent for the oral form. BNS had comparable pharmacodynamic effects of diuresis and natriuresis to IV and oral bumetanide. Fewer individuals experienced treatment-emergent adverse events after BNS treatment compared with the IV and oral forms (8.8 percent versus 9.1 and 17.9 percent, respectively).
"We were surprised by how fast the nasal spray worked and by how variable the absorption of the oral drug was even in healthy subjects," coauthor Daniel Bensimhon, M.D., of Cone Health in Greensboro, North Carolina, said in a statement.
Several authors disclosed ties to pharmaceutical companies, including Corstasis Therapeutics, which developed and manufactured the BNS tested in the study and funded the study.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted November 2024
Read this next
Better Adherence to Antipsychotics Linked to Lower Vehicle Crash Risk
MONDAY, June 9, 2025 -- For drivers with schizophrenia, better adherence to antipsychotic medications is associated with lower motor vehicle crash risk, according to a study...
Early Dog Exposure May Modify Genetic Effect on Atopic Eczema Risk
MONDAY, June 9, 2025 -- Early-life dog exposure may modify the genetic effect of the single nucleotide variant rs10214237 on atopic eczema (AE) via IL7R, according to a study...
Caregiver Concern Can Be Key to Identifying Critical Illness in Hospitalized Children
FRIDAY, June 6, 2025 -- For pediatric patients presenting to a hospital, caregiver concern for clinical deterioration is associated with critical illness, according to a study...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.