Corstasis Therapeutics Inc. Announces FDA Approval of New Drug Application for Bumetanide Nasal Spray
Monday, January 27, 2025
Corstasis Therapeutics Inc., a clinical-stage MedTech pharmaceutical company focused on developing practical treatments for fluid overload, has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its innovative Bumetanide Nasal Spray (RSQ-777). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for 14 September 2025.
The acceptance of this NDA marks a significant milestone for Corstasis Therapeutics, confirming that the application is sufficiently complete to undergo a detailed review. The Bumetanide Nasal Spray (RSQ-777) is being developed as a convenient treatment option for managing edema linked to congestive heart failure, as well as liver and kidney diseases, focusing on outpatient care.
The spray is an investigational therapy designed for non-oral loop diuretic administration through the nasal mucosa, enabling patients to manage their condition in an outpatient setting. This approach aims to ease the strain on both patients and the healthcare system by reducing the need for hospital-based treatments, potentially lowering costs while improving patients' quality of life.
Source: businesswire.com
