Corstasis Therapeutics Inc. announced that the U.S. Patent and Trade Office (USPTO) has allowed a new patent for its proprietary subcutaneous bumetanide formulations, marking a significant expansion of the company's pipeline beyond its lead product Enbumyst (bumetanide nasal spray). The patent allowance comes as the late clinical-stage biopharmaceutical company prepares for its upcoming PDUFA action date of September 14, 2025, for Enbumyst.
Subcutaneous Pipeline Development
The newly patented technology supports Corstasis's lead subcutaneous developmental programs, RSQ-786 (multidose pen injector) and RSQ-789 (smart infusion system). These innovative delivery systems would offer patients the ability to receive multiple doses in a single delivery system and potentially integrate dosing with remote patient monitoring technologies.
"The ability to integrate loop diuretic dosing with remote diagnostics and telemetry has the potential to further revolutionize the treatment of edema in patients suffering from congestive heart failure, liver and kidney disease," said Benjamin Esque, Chairman and CEO. "Securing this additional patent milestone is a key strategic achievement as Corstasis prepares Enbumyst for launch ahead of our upcoming PDUFA date later this month."
Regulatory Timeline and Market Strategy
Corstasis is targeting submission of NDA filings for its subcutaneous products in the second half of 2026. The company's New Drug Application for Enbumyst is currently under FDA review, with the PDUFA action date set for September 14, 2025.
Dr. Brian Kolski, Chief Medical Officer of Corstasis, emphasized the potential impact on patient access: "We are confident these new therapies will expand outpatient treatments for fluid overload and enhance options for patients, especially those in underserved or rural areas. We remain focused on expanding outpatient care pathways for patients and providers, and bringing value to the system as a whole."
Therapeutic Focus and Mission
Corstasis Therapeutics specializes in developing outpatient therapies for the treatment of fluid overload in patients with cardiorenal and hepatic diseases. The company's mission centers on expanding outpatient treatment options for patients with edema resulting from cardiorenal and hepatic disease, with the intent of improving outcomes and reducing overall healthcare costs.
Enbumyst bumetanide nasal spray has been developed for the short-term treatment of edema associated with congestive heart failure, liver and kidney disease. The subcutaneous formulations represent a strategic expansion of the company's loop diuretic delivery platforms, potentially offering enhanced convenience and monitoring capabilities for patients managing chronic fluid overload conditions.
