scPharmaceuticals Gains FDA Approval for Expanded FUROSCIX Use in Heart Failure

scPharmaceuticals Inc., a Burlington, Massachusetts-based pharmaceutical company, has announced the approval of its Supplemental New Drug Application (sNDA) by the Food and Drug Administration (FDA). This approval expands the indicated use of their drug FUROSCIX to include patients with New York Heart Association (NYHA) Class IV chronic heart failure. Previously, FUROSCIX was only approved for treating congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure. This expansion now makes the drug accessible to the most symptomatic heart failure patients, who constitute about 10% of the chronic heart failure population nationwide.

John Tucker, the CEO of scPharmaceuticals, emphasized that the expanded indication of FUROSCIX reflects its established efficacy and safety. He noted that the drug has the potential to prevent hospital admissions or readmissions related to heart failure. Tucker also highlighted the growing adoption of FUROSCIX among cardiologists and heart failure specialists, indicating a solid foundation for sustained long-term growth.

FUROSCIX is a furosemide injection (80 mg/10mL) designed for subcutaneous use. The drug aims to manage congestion due to fluid overload in adult patients suffering from chronic heart failure. However, it comes with specific safety information that must be noted. FUROSCIX is contraindicated in patients with anuria, those with a history of hypersensitivity to furosemide or any component of the FUROSCIX formulation, and those with hepatic cirrhosis. 

Patients treated with furosemide may experience fluid, electrolyte, and metabolic abnormalities, particularly those on higher doses or with inadequate oral electrolyte intake. These abnormalities are also more common in elderly patients. Therefore, regular monitoring of serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid levels is recommended during furosemide therapy.

Excessive diuresis can lead to dehydration and a reduction in blood volume, which might result in circulatory collapse and possibly vascular thrombosis and embolism, especially in older adults. Furosemide can also cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, the administration of furosemide should be discontinued. There have also been reports of tinnitus and both reversible and irreversible hearing impairment associated with furosemide, often linked to rapid injection, severe renal impairment, and higher-than-recommended doses.

In patients with severe urinary retention symptoms due to bladder emptying disorders, prostatic hyperplasia, or urethral narrowing, furosemide can cause acute urinary retention related to increased urine production and retention. These patients should be closely monitored, especially at the start of treatment.

Additionally, contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Patients should be able to detect and respond to alarms to mitigate this risk.

In clinical trials, the most common side effects of FUROSCIX were site and skin reactions, including erythema, bruising, edema, and injection site pain.

scPharmaceuticals is dedicated to developing and commercializing products aimed at reducing healthcare costs and improving health outcomes. The company's primary focus is the subcutaneous, self-administration of intravenous-strength treatments for conditions like heart failure and infectious diseases. This recent FDA approval represents a significant step forward in their mission to advance outpatient care for acute conditions.

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