FDA Accepts Corstasis Therapeutics' Bumetanide Nasal Spray NDA for Review
核心洞察
The FDA has accepted Corstasis Therapeutics' New Drug Application (NDA) for Bumetanide Nasal Spray (搜索) (RSQ-777) for treating edema (搜索) in heart failure, liver, and kidney disease (搜索).
The PDUFA target action date is set for September 14, 2025, indicating the timeline for the FDA's decision on the drug's approval.
Bumetanide Nasal Spray (搜索) is designed for outpatient self-administration, offering a convenient alternative to oral or intravenous loop diuretic therapy.
Corstasis Therapeutics Inc. (搜索) has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Bumetanide Nasal Spray (搜索) (RSQ-777). This investigational drug is intended for outpatient treatment of edema (搜索) associated with congestive heart failure (搜索), as well as liver and kidney disease (搜索). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025.
Benjamin Esque, CEO of Corstasis Therapeutics Inc. (搜索), stated, "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."
Potential Benefits of Bumetanide Nasal Spray
Bumetanide Nasal Spray (搜索) is designed to allow patients to self-administer a non-oral loop diuretic therapy through the nasal mucosa in an outpatient setting. This approach aims to reduce the burden on patients and the healthcare system by offering a treatment option outside of the hospital, potentially lowering costs and improving the quality of life, according to Dr. Brian Kolski, Chief Medical Officer of Corstasis Therapeutics Inc. (搜索)
Clinical Trial Data
The RSQ-777-02 trial, presented as late-breaking science at the American Heart Association (AHA) Scientific Sessions 2024, evaluated the nasal spray form of bumetanide in 68 healthy adults. The study compared the absorption and ability to reduce swelling of bumetanide nasal spray (搜索) versus the same effects of oral and intravenous (IV) bumetanide.
The results showed that bumetanide nasal spray (搜索) was absorbed effectively and remained tolerable, with consistent side effects compared to other administrations. Notably, it achieved a similar amount of urine output and blood concentration to oral and IV bumetanide, but with a 33% faster absorption rate. While IV bumetanide had faster overall absorption, the nasal form demonstrated a quicker onset of sodium excretion in urine.
Absorption Variability
The trial also highlighted the variability of absorption among different administration methods. Nasal and IV bumetanide demonstrated an absorption variability of 27%, compared to over 40% for the oral form. This suggests greater stability with nasal and IV forms, potentially giving the nasal spray an advantage over oral administration for at-home use.