The U.S. Food and Drug Administration has approved a new at-home treatment for fluid overload in patients with chronic heart failure. The therapy, called Lasix ONYU, is a drug-device combination that allows for subcutaneous, under-the-skin, infusion of a high-concentration form of furosemide, a diuretic commonly known as Lasix. This new system is designed to be used by patients at home, without the need for a healthcare professional to administer the drug.
Developed by SQ Innovation, Inc., Lasix ONYU is intended to provide an alternative to in-hospital intravenous (IV) diuretic therapy for patients experiencing worsening edema. Heart failure is a leading cause of hospitalization for Americans over 65, with approximately 1.2 million hospitalizations each year. By enabling patients to manage fluid buildup at home, the new therapy may help to reduce the number of these costly and disruptive hospital stays. The manufacturer expects to launch the product with leading health systems by the end of 2025.
A New Approach to Diuretic Therapy
Lasix ONYU consists of two main components: a reusable unit that can be used for 48 treatments and a sterile, single-use unit that is discarded after each infusion. The disposable part contains a pre-filled glass cartridge with 80 mg of furosemide in a 2.67 mL, high-concentration solution. The small, wearable infusor administers the medication subcutaneously, providing a new route of administration for a long-established drug.
High-Concentration Formulation
A key innovation in Lasix ONYU is the novel, high-concentration formulation of furosemide, at 30 mg/mL. This was achieved using Captisol technology, a drug delivery platform developed by Ligand Pharmaceuticals. Captisol is a chemically modified cyclodextrin that enhances the solubility and stability of active pharmaceutical ingredients. This technology allows for a smaller volume of liquid to be injected, making subcutaneous administration more practical and comfortable for patients.
Clinical Evidence and Bioavailability
The FDA’s approval of Lasix ONYU is supported by clinical data demonstrating its comparability to IV-administered furosemide. In a clinical study, the subcutaneous infusion showed complete bioavailability (112%) compared to an IV bolus of the same dose. The study also found that Lasix ONYU produced a similar diuretic and natriuretic response, with 115% of the urine output and 117% of the sodium loss of IV Lasix. However, the subcutaneous infusion resulted in a more tempered and sustained diuresis, while the IV administration led to a shorter period of more intense diuresis.
Impact on Patients and the Healthcare System
The at-home administration of Lasix ONYU has the potential to significantly alter how fluid overload in heart failure patients is managed. For patients, it offers the convenience and comfort of treatment in their own homes, avoiding the stress and potential complications of hospitalization. For the healthcare system, it could mean fewer emergency department visits and inpatient admissions for worsening heart failure, a major driver of healthcare costs.
Economic Considerations
The two-component design of the Lasix ONYU infusor was developed to reduce manufacturing complexity and cost. The reusable component is intended to make the therapy more affordable and accessible, which could help to lower barriers to widespread adoption. By providing a more favorable price point, the manufacturer hopes to encourage a shift from reactive, hospital-based care to proactive, home-based management of fluid overload.
The Burden of Heart Failure
Heart failure is a chronic and progressive condition that affects approximately 6.7 million Americans. This number is projected to rise to 8.7 million by 2030. One of the most common and debilitating symptoms of heart failure is edema, or fluid retention, which can cause swelling in the legs, abdomen, and lungs, leading to shortness of breath and other serious complications. Managing fluid balance is a cornerstone of heart failure therapy, and diuretics like furosemide are essential for removing excess fluid from the body.
