ScPharma's FUROSCIX Expanded Indication In Heart Failure Gets FDA Approval; Stock Down In Pre-market

(RTTNews) - scPharmaceuticals Inc. (SCPH) announced Monday that the U.S. Food and Drug Administration has approved its Supplemental New Drug Application or sNDA seeking to expand the FUROSCIX indication for heart failure patients.

FUROSCIX is indicated to treat congestion due to fluid overload in adult patients with chronic heart failure.

At approval, FUROSCIX was only indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association or NYHA Class II and Class III chronic heart failure.

The expanded indication now includes patients with NYHA Class IV chronic heart failure who represent the most symptomatic patients and those with the greatest limitation on physical activity, comprising approximately 10% of all heart failure patients nationally.

John Tucker, Chief Executive Officer of scPharma, said, "FDA approval of our sNDA represents a natural expansion of the FUROSCIX indication given its established efficacy and safety in treating congestion due to fluid overload in adult patients with chronic heart failure, offering the potential to prevent the need for heart failure-related hospital admission or readmission."

The company noted that FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation or medical adhesives and in patients with hepatic cirrhosis.

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients.

In pre-market activity on the Nasdaq, scPharma shares were losing around 9.7 percent to trade at $3.91.

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