scPharmaceuticals' sNDA for Expanding FUROSCIX to Chronic Kidney Disease Accepted

scPharmaceuticals Inc., a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted its Supplemental New Drug Application (sNDA) for FUROSCIX. This application seeks to extend the drug's indication to treat edema caused by fluid overload in patients with chronic kidney disease (CKD). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for March 6, 2025.

In feedback provided during a Type D meeting last year, the FDA indicated that no further clinical studies would be required to expand the indication, as long as the company could demonstrate an appropriate pharmacokinetic (PK) and pharmacodynamic (PD) bridge to the currently listed drug, furosemide injection.

John Tucker, Chief Executive Officer of scPharmaceuticals, highlighted that the potential expansion of FUROSCIX's indication could be pivotal for the company. He noted that CKD affects over one in seven adults in the U.S. and is often associated with frequent fluid overload episodes. Tucker also mentioned that if approved, the company is ready to deploy additional commercial resources to address what they estimate to be a $3 billion market.

FUROSCIX is a furosemide injection indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. However, it is not indicated for emergency situations or for patients with acute pulmonary edema. The On-Body Infusor administers an 80-mg dose of FUROSCIX.

FUROSCIX carries several important safety considerations. It is contraindicated in patients with anuria, a history of hypersensitivity to furosemide or medical adhesives, and in those with hepatic cirrhosis or ascites. It can cause fluid, electrolyte, and metabolic abnormalities, especially in patients receiving higher doses, those with inadequate oral electrolyte intake, and elderly patients. Frequent monitoring of serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid is recommended during furosemide therapy.

Excessive diuresis from FUROSCIX can lead to dehydration and blood volume reduction, potentially causing circulatory collapse and vascular complications, particularly in the elderly. In patients with hepatic cirrhosis and ascites, sudden fluid and electrolyte balance changes can precipitate hepatic encephalopathy and coma; therefore, treatment is best initiated in a hospital setting.

The drug can also cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment for severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and varying degrees of hearing impairment have been reported with furosemide, often related to rapid injection or higher than recommended doses, severe renal impairment, hypoproteinemia, or concurrent use of ototoxic drugs.

For patients with severe urinary retention symptoms, the increased urine production from furosemide can lead to acute urinary retention. These patients require close monitoring, especially during the initial stages of treatment.

The most common adverse reactions observed in clinical trials for FUROSCIX included site and skin reactions such as 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 focuses on innovative products that enable the outpatient care of select acute conditions, with its leading programs centered on the subcutaneous, self-administration of IV-strength treatments for heart failure and infectious diseases. The company is headquartered in Burlington, Massachusetts.