A recent study investigated a new nasal spray version of bumetanide, a widely used diuretic, and found that it is equally safe and tolerable as the oral and intravenous (IV) forms in healthy adults, without causing significant nasal issues. Oral and IV bumetanide are typically prescribed for individuals with heart failure to help alleviate tissue swelling, which is a common symptom of the condition.
The new nasal spray formulation of bumetanide may effectively alleviate the tissue swelling associated with heart failure, similar to standard oral and IV options. This finding was presented today at the American Heart Association’s Scientific Sessions 2024, held from November 16-18 in Chicago—a key global forum for sharing cutting-edge cardiovascular research and clinical practices. The study is also published today in the American Heart Association journal Circulation.
Heart failure happens when the heart is unable to pump blood effectively, leading to reduced blood flow to organs and fluid accumulation in the lungs and other areas. Making lifestyle adjustments, such as maintaining a healthy weight, quitting smoking, engaging in regular physical activity, and managing blood pressure and blood sugar levels, can help prevent heart failure.
Medications for treating heart failure include diuretics, which help to reduce tissue swelling and are available in oral or IV forms. Bumetanide is a standard diuretic used to relieve swelling caused by heart, kidney, or liver issues by eliminating excess salt and water through urine.
In the clinical trial known as RSQ-777-02, researchers assessed the new nasal spray bumetanide in healthy adults, examining its absorption and effectiveness in reducing swelling compared to the oral and IV versions among 68 participants without heart failure or associated risk factors.
According to Daniel Bensimhon, M.D., medical director of the Advanced Heart Failure/Mechanical Circulatory Support Program at Cone Health in Greensboro, North Carolina, “In heart failure patients, the body’s ability to absorb oral medications is often compromised due to fluid overload, which can lead to diuretic resistance. Therefore, having a diuretic that works without relying on gut absorption may prove invaluable for heart failure patients and others, as it eliminates the need for IV administration typically given at hospitals or clinics.”
The study yielded the following results:
- The nasal spray was effectively absorbed and displayed a safety profile comparable to the other forms, with fewer adverse events reported compared to the oral version.
- Urine output was similar for the nasal spray when compared to oral and IV bumetanide.
- Participants using the nasal spray achieved a comparable blood concentration to those taking the oral version, with absorption occurring 33% faster. While IV bumetanide had a faster absorption rate than both the nasal and oral versions, the nasal form expedited sodium excretion in urine, which has been identified in previous research as a marker for diuretic effectiveness in heart failure.
- All participants received all three formulations of bumetanide in different sequences. Notably, absorption rates for the nasal and IV forms were more consistent than the oral version for each participant, indicated by a lower variability in rates (27% for nasal and IV vs. over 40% for oral), suggesting that the nasal and IV options may offer a more reliable dosing method. This could favor the nasal spray for self-administration at home.
Bensimhon expressed surprise at how quickly the nasal spray took effect and the variability of oral drug absorption even among healthy individuals, stating, “For patients requiring diuretic treatment for swelling linked to chronic heart failure and liver disease, this new self-administered option may be beneficial, especially when oral medications are ineffective or hard to take.”
A limitation of the study is that participants were generally healthy, without heart failure or risk factors at enrollment. With safety and tolerability now established in healthy adults, the researchers plan to conduct further studies on the bioavailability and clinical effectiveness of intranasal bumetanide in patients with heart failure.
Bensimhon emphasized, “We believe this could be a significant tool for managing heart failure by enabling at-home care, potentially reducing the need for expensive hospital stays and readmissions. Keeping patients at home benefits both individuals and health systems.”
Further details on the study include:
- The RSQ-777-02 trial was conducted at the Orange County Research Center in Irvine, California, from December 2023 to April 2024.
- The study involved 68 healthy adults aged 18 to 55, all free of heart failure or related risk factors at enrollment.
- 66.2% of participants were men, while 33.8% were women. Ethnically, 60.3% identified as white, 27.9% as Black, 10.3% as Asian, and 1.5% as “other.” Additionally, 32.4% identified as Hispanic or Latino, and 67.6% as non-Hispanic or Latino.
- Each participant received the nasal, oral, and IV forms of bumetanide in a varied sequence.
- Participants were monitored on-site for a duration of 10 days.
Details about co-authors, disclosures, and funding sources are included in the study abstract. The research was funded and developed by Corstasis, the developer of the nasal spray formulation, and carried out independently by the Orange County Research Center.
