scPharmaceuticals Inc. announced that the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives. The Company announced FDA feedback from a Type C meeting pertaining to the development of an 80mg/1mL auto-injector intended to provide an additional option to the on-body infusor for treatment of congestion due to fluid overload in eligible adult patients who do not require hospitalization. The Company expects that an auto-injector, if successfully developed and approved, would reduce manufacturing costs compared to the current on-body infusor and confer environmental advantages.

scPharmaceuticals plans to report data from a pivotal pharmacokinetic (PK) study in first half of 2024, and, if successful, targets submitting a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024. The Company also announced feedback from a Type D meeting with the FDA pertaining to the potential expansion of the FUROSCIX label to include treatment of edema due to fluid overload in patients with CKD. In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that the Company demonstrates an adequate PK and pharmacodynamic bridge to the listed drug, furosemide injection, 10 mg/mL.

CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics.