MONDAY, Nov. 25, 2024 (HealthDay News) -- 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.
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